HUIZHOU JINSHENG MEDICAL TECHNOLOGY CO., LTD
FDA
OTC
Straighten the cleaning solution Pour it into the cleaning position for cleaning Usage: This product is designed for gentle cleaning of the face, mouth, nose, eyes,ears, and wounds. It can also be used with a nebulizer to help relieve discomfort in the nose and mouth.
Saline Solution is intended for use in OTC ear,nose,and throat devices intended specifically to administer medicinal substances to treat ear,nose,and throat disorders.These instruments include the powder blower,dropper,ear wick,manual nebulizer pump,and nasal inhaler. If using with an OTC ear,nose,or throat device,the follow the directions provided with the device and only use as directed.
HUIZHOU JINSHENG MEDICAL TECHNOLOGY CO., LTD
FDA
OTC
Usage: This product is designed for gentle cleaning of the face, mouth, nose, eyes, ears, and wounds. It can also be used with a nebulizer to help relieve discomfort in the nose and mouth.
HF ACQUISITION CO LLC, DBA HEALTHFIRST
FDA
Rx Only
Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. The pH ranges from 4.5 to 7.0. Composition, osmolarity, and ionic concentration are shown below: 0.9% Sodium Chloride Injection, USP contains 9 g/L Sodium Chloride, USP (NaCl) with an osmolarity of 308 mOsmol/L (calc). It contains 154 mEq/L sodium and 154 mEq/L chloride. The FLEBOFLEX and FLEBOFLEX LUER plastic containers are fabricated from latex-free polyolefins or polypropylene plastic materials. The solution contact materials do not contain PVC, DEHP, or other plasticizers. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. The suitability of the container materials has been established through biological evaluations, which have shown the containers pass Class VI U.S. Pharmacopeia (USP) testing for plastic containers. These tests confirm the biological safety of the container systems.
HF ACQUISITION CO LLC, DBA HEALTHFIRST
FDA
Rx Only
This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. 0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. Each mL contains sodium chloride 9 mg. It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. 0.308 mOsmol/mL (calc.). 0.9% Sodium Chloride Injection, USP contains no preservatives. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. pH 5.3 (4.5 to 7.0). Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water. The glass container is a Type I borosilicate glass and meets the requirements of the powdered glass test according to the USP standards. The semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.
HF ACQUISITION CO LLC, DBA HEALTHFIRST
FDA
Rx Only
Sodium Chloride Injection, USP solutions are sterile and nonpyrogenic. They are parenteral solutions containing various concentrations of sodium chloride in water for injection intended for intravenous administration. For 0.45% Sodium Chloride Injection, USP, each 100 mL contains 450 mg sodium chloride in water for injection. Electrolytes per 1000 mL: sodium 77 mEq; chloride 77 mEq. The osmolarity is 154 mOsmol/L (calc.). For 0.9% Sodium Chloride Injection, USP, each 100 mL contains 900 mg sodium chloride in water for injection. Electrolytes per 1000 mL: sodium 154 mEq; chloride 154 mEq. The osmolarity is 308 mOsmol/L (calc.). The pH for both concentrations in the 100 mL and smaller containers is 6.0; for the 250 mL and larger containers, the pH is 5.6. The pH range is 4.5 to 7.0 for all containers. The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solutions are parenteral fluid and electrolyte replenishers. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.
HF ACQUISITION CO LLC, DBA HEALTHFIRST
FDA
Rx Only
Sodium Chloride Injection, USP solutions are sterile and nonpyrogenic. They are parenteral solutions containing various concentrations of sodium chloride in water for injection intended for intravenous administration. For 0.45% Sodium Chloride Injection, USP, each 100 mL contains 450 mg sodium chloride in water for injection. Electrolytes per 1000 mL: sodium 77 mEq; chloride 77 mEq. The osmolarity is 154 mOsmol/L (calc.). For 0.9% Sodium Chloride Injection, USP, each 100 mL contains 900 mg sodium chloride in water for injection. Electrolytes per 1000 mL: sodium 154 mEq; chloride 154 mEq. The osmolarity is 308 mOsmol/L (calc.). The pH for both concentrations in the 100 mL and smaller containers is 6.0; for the 250 mL and larger containers, the pH is 5.6. The pH range is 4.5 to 7.0 for all containers. The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solutions are parenteral fluid and electrolyte replenishers. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.
HF ACQUISITION CO LLC, DBA HEALTHFIRST
FDA
Rx Only
Sodium Chloride Injection, USP solutions are sterile and nonpyrogenic. They are parenteral solutions containing various concentrations of sodium chloride in water for injection intended for intravenous administration. For 0.45% Sodium Chloride Injection, USP, each 100 mL contains 450 mg sodium chloride in water for injection. Electrolytes per 1000 mL: sodium 77 mEq; chloride 77 mEq. The osmolarity is 154 mOsmol/L (calc.). For 0.9% Sodium Chloride Injection, USP, each 100 mL contains 900 mg sodium chloride in water for injection. Electrolytes per 1000 mL: sodium 154 mEq; chloride 154 mEq. The osmolarity is 308 mOsmol/L (calc.). The pH for both concentrations in the 100 mL and smaller containers is 6.0; for the 250 mL and larger containers, the pH is 5.6. The pH range is 4.5 to 7.0 for all containers. The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solutions are parenteral fluid and electrolyte replenishers. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.
HF ACQUISITION CO LLC, DBA HEALTHFIRST
FDA
Rx Only
0.9% Sodium Chloride Injection, USP solution is sterile and nonpyrogenic. It is a parenteral solution containing sodium chloride in water for injection intended for intravenous administration. For 0.9% Sodium Chloride Injection, USP, each 100 mL contains 900 mg sodium chloride in water for injection. Electrolytes per 1,000 mL: sodium 154 mEq; chloride 154 mEq. The osmolarity is 308 mOsmol/L (calc.). The pH in the 100 mL and smaller containers is 6.0; for the 250 mL and larger containers, the pH is 5.6. The pH range is 4.5 to 7.0 for all containers. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solution is a parenteral fluid and electrolyte replenisher. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for injection, USP is chemically designated H2O. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.
12 CELL SALTS COMPLEXCALCAREA FLUORICA CALCAREA PHOSPHORICA CALCAREA SULPHURICA FERRUM PHOSPHORICUM KALI MURIATICUM KALI PHOSPHORICUM KALI SULPHURICUM MAGNESIA PHOSPHORICA NATRUM MURIATICUM NATRUM PHOSPHORICUM NATRUM SULPHURICUM SILICEA
INDICATIONS: For weight management and inflammation support. This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
3% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, hypertonic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. The pH may have been adjusted with hydrochloric acid. It contains no antimicrobial agents. Composition, ionic concentration, osmolarity, and pH are shown in Table 1 . Table 1. *Normal physiological osmolarity range is approximately 280 to 310 mOsmol/L. Size (mL) Composition (g/L) Ionic Concentration (mEq/L) *Osmolarity (mOsmol/L) (calc) pH Sodium Chloride, USP (NaCl) Sodium Chloride 3% Sodium Chloride Injection, USP 500 30 513 513 1,027 5.0 (4.5 to 7.0) The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (free flex ® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.
4 Kids Cold and Cough DaytimeONION CALCIUM SULFIDE SODIUM CHLORIDE PHOSPHORUS PULSATILLA VULGARIS SULFUR AND GOLDENSEAL
Uses* ■ Helps temporarily relieve symptoms of common cold in children at night, including: ■ cough ■ runny nose ■ post nasal drip ■ sneezing ■ sore throat ■ nasal or chest congestion ■ occasional sleeplessness
Uses ■ Helps temporarily relieve symptoms of common cold in children at night, including: ■ cough ■ runny nose ■ post nasal drip ■ sneezing ■ sore throat ■ nasal or chest congestion ■ occasional sleeplessness
4 Kids Cold and Mucus NighttimeEUPHRASIA STRICTASILICON DIOXIDE RUMEX CRISPUS ROOT ANEMONE PULSATILLA GOLDENSEAL SODIUM CHLORIDE PHOSPHORUS ONION BRYONIA ALBA ROOT MATRICARIA CHAMOMILLA ARABICA COFFEE BEAN CALCIUM SULFIDE AND SULFUR
Uses Temporarily relieves the symptoms of the common cold in children especially at night including accumulation of mucus in chest, throat and nose, cough with mucus, runny nose, sneezing, nasal congestion and occasional sleeplessness.
4 KIDS COLD N COUGH GRAPE FLAVORONION CALCIUM SULFIDE GOLDENSEAL SODIUM CHLORIDE PHOSPHORUS ANEMONE PULSATILLA AND SULFUR
Uses ■Temporarily relieves symptoms of common cold in children, including: ■ accumulation of mucus in chest, throat or nose ■ cough with expectoration of thick, discolored mucus ■ runny nose ■ sneezing ■ nasal or chest congestion
4 Kids Stuffy Nose and SinusPULSATILLA PRATENSIS WHOLEOYSTER SHELL CALCIUM CARBONATE CRUDEGOLDENSEAL AND POTASSIUM DICHROMATE
INDICATIONS: May temporarily relieve symptoms associated with decreased lymphatic drainage of the organs, such as fatigue, headache, lymphatic swelling, and bad effects from sedentary habits.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Energize Sarcolacticum Acidum, Viscum Album, Iodium, Colchicum Autumnale, Conium Maculatum, Fucus Vesiculosus, Galium Aparine, Natrum Oxalaceticum, Thyroidinum (Suis), DHEA (Dehydroepiandrosterone), Phenyl Isothiocyanate, Tri-Iodothyronine, Tyramine, Alpha-Ketoglutaricum Acidum, Adenosinum Triphosphoricum Dinatrum, Fumaricum Acidum, Malic Acid, Funiculus Umbilicalis Suis, Hepar Suis, Medulla Ossis Suis, Pineal Gland (Suis), Spleen (Suis), Thymus (Suis), Calcarea Fluorica, Pulsatilla (Vulgaris) LACTIC ACID, L- LACTIC ACID, L- VISCUM ALBUM FRUITING TOP VISCUM ALBUM FRUITING TOP IODINE IODINE COLCHICUM AUTUMNALE BULB COLCHICUM AUTUMNALE BULB CONIUM MACULATUM FLOWERING TOP CONIUM MACULATUM FLOWERING TOP FUCUS VESICULOSUS FUCUS VESICULOSUS GALIUM APARINE GALIUM APARINE SODIUM DIETHYL OXALACETATE DIETHYL OXALACETATE THYROID, PORCINE SUS SCROFA THYROID PRASTERONE PRASTERONE PHENYL ISOTHIOCYANATE PHENYL ISOTHIOCYANATE LIOTHYRONINE LIOTHYRONINE TYRAMINE TYRAMINE .ALPHA.-KETOGLUTARIC ACID .ALPHA.-KETOGLUTARIC ACID ADENOSINE TRIPHOSPHATE DISODIUM ADENOSINE TRIPHOSPHATE FUMARIC ACID FUMARIC ACID MALIC ACID MALIC ACID SUS SCROFA UMBILICAL CORD SUS SCROFA UMBILICAL CORD PORK LIVER PORK LIVER SUS SCROFA BONE MARROW SUS SCROFA BONE MARROW SUS SCROFA PINEAL GLAND SUS SCROFA PINEAL GLAND SUS SCROFA SPLEEN SUS SCROFA SPLEEN SUS SCROFA THYMUS SUS SCROFA THYMUS CALCIUM FLUORIDE FLUORIDE ION PULSATILLA VULGARIS ANEMONE PULSATILLA SPONGIA OFFICINALIS SKELETON, ROASTED SPONGIA OFFICINALIS SKELETON, ROASTED CORTISONE ACETATE CORTISONE MERCURIC CHLORIDE MERCURIC CATION SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS ESCHERICHIA COLI ESCHERICHIA COLI WATER ALCOHOL
HOMEOPATHIC INDICATIONS: For temporary relief of symptoms related to the thyroid system.** **These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.
Advanced Detox Core Formula Dulcamara, Echinacea Angustifolia, Aesculus Hippocastanum, Antimonium Tartaricum, Ascorbic Acid, Coccus Cacti, Conium Maculatum, Galium Aparine, Gentiana Lutea, Geranium Robertianum, Pulsatilla (Vulgaris), Sarcolacticum Acidum, Lymph Node (Suis), Sulphur, Glandula Suprarenalis Suis, L-Phenylalanine, Calcarea Phosphorica, Ferrum Phosphoricum, Hepar Suis, Hypothalamus (Suis), Spleen (Suis), Cortisone Aceticum, Mercurius Solubilis, Baryta Carbonica, Tonsil (Suis), Funiculus Umbilicalis Suis, Gaertner Bacillus, SOLANUM DULCAMARA TOP SOLANUM DULCAMARA TOP ECHINACEA ANGUSTIFOLIA ECHINACEA ANGUSTIFOLIA HORSE CHESTNUT HORSE CHESTNUT ANTIMONY POTASSIUM TARTRATE ANTIMONY CATION (3+) ASCORBIC ACID ASCORBIC ACID PROTORTONIA CACTI PROTORTONIA CACTI CONIUM MACULATUM FLOWERING TOP CONIUM MACULATUM FLOWERING TOP GALIUM APARINE GALIUM APARINE GENTIANA LUTEA ROOT GENTIANA LUTEA ROOT GERANIUM ROBERTIANUM GERANIUM ROBERTIANUM PULSATILLA VULGARIS PULSATILLA VULGARIS LACTIC ACID, L- LACTIC ACID, L- SUS SCROFA LYMPH SUS SCROFA LYMPH SULFUR SULFUR SUS SCROFA ADRENAL GLAND SUS SCROFA ADRENAL GLAND PHENYLALANINE PHENYLALANINE TRIBASIC CALCIUM PHOSPHATE CALCIUM CATION FERROSOFERRIC PHOSPHATE FERROSOFERRIC PHOSPHATE PORK LIVER PORK LIVER SUS SCROFA HYPOTHALAMUS SUS SCROFA HYPOTHALAMUS SUS SCROFA SPLEEN SUS SCROFA SPLEEN CORTISONE ACETATE CORTISONE MERCURIUS SOLUBILIS MERCURIUS SOLUBILIS BARIUM CARBONATE BARIUM CATION SUS SCROFA TONSIL SUS SCROFA TONSIL SUS SCROFA UMBILICAL CORD SUS SCROFA UMBILICAL CORD SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS LIOTHYRONINE LIOTHYRONINE SUS SCROFA BONE MARROW SUS SCROFA BONE MARROW ESCHERICHIA COLI ESCHERICHIA COLI WATER ALCOHOL
HOMEOPATHIC INDICATIONS: Temporary relief of symptoms related to improper breakdown and excretion of allergenic substances including chronic pain, fatigue, cramping and upper respiratory allergy.** **These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.
HOMEOPATHIC INDICATIONS: For temporary relief of symptoms related to yeast, including constipation, mucous congestion, occasional abdominal gas, headaches, fatigue, alcohol cravings, anxiety, vaginitis, rectal itching, cravings for sweets, foggy brain, mood swings, occasional diarrhea and dizziness.** **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.
INDICATIONS: For temporary relief of pain in the abdomen extending around to the back, pain in the thighs and loins on urinating and frequent urination.
HOMEOPATHIC INDICFATIONS: For the temporary relief of symptoms such as discomfort, swelling and joint pain that result from arthritis or neurological diseases.** **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.
HOMEOPATHIC INDICATIONS: Temporary relief of symptoms related to blocked energy in the region of the mid abdomen including indigestion, fatigue, bloating, cramping and abdominal anxiety.** **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.
HOMEOPATHIC INDICATIONS: For temporary relief of symptoms related to parasite infestation including diarrhea, digestive problems, flatulence, constipation, and spasms.** **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.
Epinephrine Adrenalinum EPINEPHRINE EPINEPHRINE WATER ALCOHOL
HOMEOPATHIC INDICATIONS: For the temporary relief of symptoms including anxiety attacks, exhaustion, congestion, and stress.** **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.
Condylomata Homochord Human Papilloma Nosode HUMAN PAPILLOMAVIRUS HUMAN PAPILLOMAVIRUS WATER ALCOHOL
HOMEOPATHIC INDICATIONS: For the temporary relief of symptoms related to Human Papilloma Virus including itching in the pelvic area.** **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.
PMS Tone Angelica archangelica, Cimicifuga racemosa, ANGELICA ARCHANGELICA ROOT ANGELICA ARCHANGELICA ROOT BLACK COHOSH BLACK COHOSH FUCUS VESICULOSUS FUCUS VESICULOSUS COPPER COPPER LACHESIS MUTA VENOM LACHESIS MUTA VENOM LYCOPODIUM CLAVATUM SPORE LYCOPODIUM CLAVATUM SPORE SODIUM CHLORIDE SODIUM CATION PULSATILLA VULGARIS PULSATILLA VULGARIS SEPIA OFFICINALIS JUICE SEPIA OFFICINALIS JUICE WATER ALCOHOL CANIS LUPUS FAMILIARIS MILK CANIS LUPUS FAMILIARIS MILK
HOMEOPATHIC INDICATIONS: For the temporary relief of symptoms related to watery diarrhea, irritation of stomach, indigestion, abdominal bloating, stomach cramps, and loss of appetite.** **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.
Male Energy Dehydroepiandrosterone, Sabal serrulata, Setotonin, Orchitinum (suis), Pituitary (suis), Thyroidinum (suis), Conium maculatum, Testosterone, PRASTERONE PRASTERONE SAW PALMETTO SAW PALMETTO SEROTONIN SEROTONIN SUS SCROFA TESTICLE SUS SCROFA TESTICLE SUS SCROFA PITUITARY GLAND, POSTERIOR SUS SCROFA PITUITARY GLAND, POSTERIOR THYROID, PORCINE THYROID, PORCINE CONIUM MACULATUM FLOWERING TOP CONIUM MACULATUM FLOWERING TOP TESTOSTERONE TESTOSTERONE ALCOHOL WATER
HOMEOPATHIC INDICATIONS: For temporary relief of symptoms related to the respiratory system.** **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.
HOMEOPATHIC INDICATIONS: For the temporary relief of symptoms of emotional distress, nervous anxiety, and nervous exhaustion.** **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.
Cinnamic Acid Cinnamic Acid CINNAMIC ACID CINNAMIC ACID WATER ALCOHOL
HOMEOPATHIC INDICATIONS: For temporary relief of skin rashes, general fatigue, craving for fruit, headaches, and indigestion.** **These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.
HOMEOPATHIC INDICATIONS: For temporary relief of symptoms of improper digestion, nasal sinus congestion and sleep disorders.** **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.
HOMEOPATHIC INDICATIONS: For temporary relief of symptoms related to high blood sugar including dry mouth, thirst, night sweats, sugar and carb cravings.** **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.