Signature Care Hemorrhoidal Cream + Aloe Max. Strength Pain Relief W/applicator 2 Oz Zdp 78981

Signature Care Hemorrhoidal Cream + Aloe Max. Strength Pain Relief W/applicator 2 Oz Zdp 78981
SPL v4
SPL
SPL Set ID b026a386-5e38-52ed-e053-2a95a90a6b0e
Route
TOPICAL
Published
Effective Date 2021-01-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (2.5 mg) Pramoxine (10 mg) Glycerin (144 mg) Petrolatum (150 mg)
Inactive Ingredients
Steareth-20 Propylene Glycol Methylparaben Propylparaben Butylated Hydroxytoluene Water Cetyl Palmitate Cetyl Esters Wax Stearic Acid .alpha.-tocopherol Acetate Aloe Vera Leaf Lanolin Glyceryl Monostearate Trisodium Citrate Dihydrate Isopropyl Myristate Cetostearyl Alcohol Light Mineral Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-04

Description

Active ingredients Purpose Glycerin 14.4%............................................................Skin protectant Phenylephrine HCl 0.25%...........................................Vasconstrictor Pramoxine HCl 1%......................................................Local anesthetic White petrolatum 15%.................................................Skin protectant


Medication Information

Warnings and Precautions

Warnings

For external and/or intrarectal use only

Indications and Usage

Directions

  • adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying cream.
  • when first opening the tube, peel back foil seal
  • apply externally or in the lower portion of the anal canal only
  • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • for application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into the anus
  • thoroughly cleanse dispensing cap after each use and replace cover
  • children under 12 years of age: ask a doctor
Dosage and Administration

Distributed by:

Better Living Brands LLC

Made in China

Description

Active ingredients Purpose Glycerin 14.4%............................................................Skin protectant Phenylephrine HCl 0.25%...........................................Vasconstrictor Pramoxine HCl 1%......................................................Local anesthetic White petrolatum 15%.................................................Skin protectant

Section 44425-7

Other information

  • store at room temperature 20-25°C (68-77°F)
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9

Stop use and ask a doctor if

  • condition worsens or does not improve within 7 days
  • bleeding occurs
  • an allergic reaction develops
  • the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
Section 50567-7

When using this product

  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator
Section 50569-3

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • difficult in urination due to enlargement of the prostate gland
  • diabetes
Section 51727-6

Inactive ingredients

.alpha.-tocopherol acetate, aloe vera leaf, anhydrous lanolin, butylated hydroxytoluene, cetostearyl alcohol, cetyl esters wax, cetyl palmitate, glycryl monostearate, isopropyl myristate, light mineral oil, methylparaben, propylene glycol, propylparaben, purified water, steareth-20, stearic acid, trisodium citrate dihydrate

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Uses

  • for temporary relief of pain, soreness and burning
  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoidal tissue
  • temporarily provides a coating for relief of anorectal discomforts
  • temporarily protects the inflamed, irritated anorectal surface to make bowel movements less painful
Section 55106-9

Active ingredients Purpose

Glycerin 14.4%............................................................Skin protectant

Phenylephrine HCl 0.25%...........................................Vasconstrictor

Pramoxine HCl 1%......................................................Local anesthetic

White petrolatum 15%.................................................Skin protectant


Structured Label Content

Indications and Usage (34067-9)

Directions

  • adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying cream.
  • when first opening the tube, peel back foil seal
  • apply externally or in the lower portion of the anal canal only
  • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • for application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into the anus
  • thoroughly cleanse dispensing cap after each use and replace cover
  • children under 12 years of age: ask a doctor
Dosage and Administration (34068-7)

Distributed by:

Better Living Brands LLC

Made in China

Warnings and Precautions (34071-1)

Warnings

For external and/or intrarectal use only

Section 44425-7 (44425-7)

Other information

  • store at room temperature 20-25°C (68-77°F)
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • condition worsens or does not improve within 7 days
  • bleeding occurs
  • an allergic reaction develops
  • the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
Section 50567-7 (50567-7)

When using this product

  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • difficult in urination due to enlargement of the prostate gland
  • diabetes
Section 51727-6 (51727-6)

Inactive ingredients

.alpha.-tocopherol acetate, aloe vera leaf, anhydrous lanolin, butylated hydroxytoluene, cetostearyl alcohol, cetyl esters wax, cetyl palmitate, glycryl monostearate, isopropyl myristate, light mineral oil, methylparaben, propylene glycol, propylparaben, purified water, steareth-20, stearic acid, trisodium citrate dihydrate

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Uses

  • for temporary relief of pain, soreness and burning
  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoidal tissue
  • temporarily provides a coating for relief of anorectal discomforts
  • temporarily protects the inflamed, irritated anorectal surface to make bowel movements less painful
Section 55106-9 (55106-9)

Active ingredients Purpose

Glycerin 14.4%............................................................Skin protectant

Phenylephrine HCl 0.25%...........................................Vasconstrictor

Pramoxine HCl 1%......................................................Local anesthetic

White petrolatum 15%.................................................Skin protectant


Advanced Ingredient Data


Raw Label Data

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