Biomega™

Biomega™
SPL v1
SPL
SPL Set ID ca938e5d-8c61-4085-9271-aba13e9395b4
Route
TOPICAL
Published
Effective Date 2016-09-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (2.5 mg)
Inactive Ingredients
Water Aloe Vera Leaf Methyl Diisopropyl Propionamide Ethyl Menthane Carboxamide Menthyl Lactate, (-)- Lauryl Laurate Starch, Corn Hydrated Silica Glucosamine Hydrochloride Dimethyl Sulfone Glycerin Sunflower Oil Alfalfa Arnica Montana Flower Cymbopogon Schoenanthus Top Rosemary Mentha Piperita Leaf Asian Ginseng Ginkgo Flax Seed Celosia Argentea Seed Acai Edetate Disodium Emu Oil Polysorbate 20 .alpha.-tocopherol Acetate Butylene Glycol Phenoxyethanol Caprylyl Glycol Ethylhexylglycerin Hexylene Glycol Cetearyl Isononanoate Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol Glyceryl Monostearate Ceteareth-12 Cetyl Palmitate Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-08-31

Description

Drug Facts

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Drug Facts

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • sprains
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away. If inhaled, remove to fresh air. If breathing is difficult get medical attention immediately.

Section 50566-9

Discontinue use and consult a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days. Stop using and get immediate medical attention if experience burning, pain, swelling or blistering of the skin. Rare cases of severe burning or blistering have been reported.

Section 50570-1
  • This is not a face cream. Do not apply to the face.
  • Do not use if allergic to chili peppers or if past allergic reaction to capsaicin.
  • Do not apply to wounds or damaged, broken, sunburned, chapped or irritated skin.
  • Do not bandage tightly.
  • Do not apply within 1 hour before or after bath, shower, hot tub, sauna or vigorous exercise. Warm water, perspiration or open pores can intensify the impact of this product and burning sensation.
  • Do not use with heating pad, hot water bottle or other source of heat Doing so can increase risk of serious burns.
Section 53414-9

If pregnant, breast-feeding or any medical conditions exist ask a health professional before use.

Warnings

For external use only.

Directions
  • Rotate pump's spout counter-clockwise slightly to unlock; clockwise to lock.
  • Before using on children under 18 years of age consult a physician.
  • Apply sparingly to affected area not more than 4 times daily. However, for first use, apply to small skin area to test for sensitivity or skin reaction.
  • Gently massage into the skin until fully absorbed.
  • Wash hands with soap and water thoroughly after each application to avoid spreading to the eyes or other sensitive mucous membranes.
  • A burning sensation may occur upon initial application but generally disappears with continued use. For a severe burning discomfort remove excess product with a soft cloth and cooking oil.
Active Ingredient

Capsicum Oleoresin 0.0625%

(Containing Capsaicin 0.025%)

Inactive Ingredients

Water (Aqua), Butylene Glycol, Glycerin, Aloe Barbadensis Leaf Juice, Helianthus Annuus (Sunflower) Seed Oil, Medicago Sativa (Alfalfa) Extract, Arnica Montana Flower Extract, Cymbopogon Schoenanthus Stem/Leaf/Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Panax Ginseng Root Extract, Ginkgo Biloba Leaf Extract, Linum Usitatissimum (Linseed) Seed Extract, Celosia Argentea Seed Extract, Euterpe Oleracea Fruit Extract, Mentha Piperita Leaf Extract, Glucosamine HCl, Dimethyl Sulfone, Hydrolyzed Corn Starch, Lauryl Laurate, Methyl Diisopropyl Propionamide, Ethyl Menthane Carboxamide, Menthyl Lactate, Hydrated Silica, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch Octenylsuccinate, Cetearyl Isononanoate, Ceteareth-20, Cetearyl Alcohol, Glyceryl Stearate, Ceteareth-12, Cetyl Palmitate, Emu Oil, Polysorbate 20, Acrylates/C 10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Sodium Hydroxide.

Questions Or Comments?

Call toll-free 1-877-630-9788 or visit us at www.biomegard.com

When Using This Product
  • Do not get into eyes and avoid contact with other mucous membranes. If contact occurs or if pain, discomfort or skin redness occurs, continually rinse with cool water and seek medical help.
Principal Display Panel 237 Ml Bottle Label

BIOMEGA™

Penetrating

HEAT PAIN THERAPY Cream

with Heating Capsaicin

  • Omegas 3,6 & 9
  • With Natural Ingredients
  • Ice Pearls™ Technology

    For Hours Of Therapy

Paraben-free topical analgesic for

Arthritis • Joint Pain • Muscle Ache • Cramps


Structured Label Content

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • sprains
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away. If inhaled, remove to fresh air. If breathing is difficult get medical attention immediately.

Section 50566-9 (50566-9)

Discontinue use and consult a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days. Stop using and get immediate medical attention if experience burning, pain, swelling or blistering of the skin. Rare cases of severe burning or blistering have been reported.

Section 50570-1 (50570-1)
  • This is not a face cream. Do not apply to the face.
  • Do not use if allergic to chili peppers or if past allergic reaction to capsaicin.
  • Do not apply to wounds or damaged, broken, sunburned, chapped or irritated skin.
  • Do not bandage tightly.
  • Do not apply within 1 hour before or after bath, shower, hot tub, sauna or vigorous exercise. Warm water, perspiration or open pores can intensify the impact of this product and burning sensation.
  • Do not use with heating pad, hot water bottle or other source of heat Doing so can increase risk of serious burns.
Section 53414-9 (53414-9)

If pregnant, breast-feeding or any medical conditions exist ask a health professional before use.

Purpose

Topical Analgesic

Warnings

For external use only.

Directions
  • Rotate pump's spout counter-clockwise slightly to unlock; clockwise to lock.
  • Before using on children under 18 years of age consult a physician.
  • Apply sparingly to affected area not more than 4 times daily. However, for first use, apply to small skin area to test for sensitivity or skin reaction.
  • Gently massage into the skin until fully absorbed.
  • Wash hands with soap and water thoroughly after each application to avoid spreading to the eyes or other sensitive mucous membranes.
  • A burning sensation may occur upon initial application but generally disappears with continued use. For a severe burning discomfort remove excess product with a soft cloth and cooking oil.
Active Ingredient (Active ingredient)

Capsicum Oleoresin 0.0625%

(Containing Capsaicin 0.025%)

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Butylene Glycol, Glycerin, Aloe Barbadensis Leaf Juice, Helianthus Annuus (Sunflower) Seed Oil, Medicago Sativa (Alfalfa) Extract, Arnica Montana Flower Extract, Cymbopogon Schoenanthus Stem/Leaf/Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Panax Ginseng Root Extract, Ginkgo Biloba Leaf Extract, Linum Usitatissimum (Linseed) Seed Extract, Celosia Argentea Seed Extract, Euterpe Oleracea Fruit Extract, Mentha Piperita Leaf Extract, Glucosamine HCl, Dimethyl Sulfone, Hydrolyzed Corn Starch, Lauryl Laurate, Methyl Diisopropyl Propionamide, Ethyl Menthane Carboxamide, Menthyl Lactate, Hydrated Silica, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch Octenylsuccinate, Cetearyl Isononanoate, Ceteareth-20, Cetearyl Alcohol, Glyceryl Stearate, Ceteareth-12, Cetyl Palmitate, Emu Oil, Polysorbate 20, Acrylates/C 10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Sodium Hydroxide.

Questions Or Comments? (Questions or comments?)

Call toll-free 1-877-630-9788 or visit us at www.biomegard.com

When Using This Product (When using this product)
  • Do not get into eyes and avoid contact with other mucous membranes. If contact occurs or if pain, discomfort or skin redness occurs, continually rinse with cool water and seek medical help.
Principal Display Panel 237 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label)

BIOMEGA™

Penetrating

HEAT PAIN THERAPY Cream

with Heating Capsaicin

  • Omegas 3,6 & 9
  • With Natural Ingredients
  • Ice Pearls™ Technology

    For Hours Of Therapy

Paraben-free topical analgesic for

Arthritis • Joint Pain • Muscle Ache • Cramps


Advanced Ingredient Data


Raw Label Data

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