Equate™ Hydrocortisone Cream 1% Intensive Healing Formula

Equate™ Hydrocortisone Cream 1% Intensive Healing Formula
SPL v3
SPL
SPL Set ID f5c32b4a-1159-4b7a-b8ac-256d53020dc2
Route
TOPICAL
Published
Effective Date 2025-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Aloe Vera Leaf Ammonium Acryloyldimethyltaurate/vp Copolymer Yellow Wax Carbomer Homopolymer, Unspecified Type Ceteareth-6 Cetyl Alcohol Citric Acid Monohydrate Coconut Oil Starch, Corn Dimethicone Edetate Disodium Anhydrous Glycerin Isopropyl Palmitate Methylparaben Mineral Oil Propylene Glycol Propylparaben Shea Butter Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-11-18

Description

Drug Facts

Purpose

Antipruritic (anti-itch)


Medication Information

Purpose

Antipruritic (anti-itch)

Description

Drug Facts

Uses
  • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
    • eczema
    • psoriasis
    • poison ivy, oak, sumac
    • insect bites
    • detergents
    • jewelry
    • cosmetics
    • soaps
    • seborrheic dermatitis
  • temporarily relieves external anal and genital itching
  • other uses of this product should only be under the advice and supervision of a doctor
Section 42229-5

Drug Facts

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 53414-9

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

Warnings

For external use only.

Directions
  • for itching of skin irritation, inflammation, and rashes:
    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: ask a doctor
  • for external anal and genital itching, adults:
    • when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
    • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
    • apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age: ask a doctor
Do Not Use
  • in the genital area if you have a vaginal discharge. Consult a doctor.
  • for the treatment of diaper rash. Consult a doctor.
Active Ingredient

Hydrocortisone 1%

Other Information
  • store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.
Inactive Ingredients

aloe barbadensis leaf juice, ammonium acryloyldimethyltaurate/VP copolymer, bees wax, carbomer, ceteareth-6, cetyl alcohol, citric acid, coconut oil, corn starch, dimethicone, disodium EDTA, glycerin, isopropyl palmitate, methylparaben, mineral oil, propylene glycol, propylparaben, shea butter, sodium citrate, sodium lauryl sulfate, tocopheryl (vitamin E) acetate, white petrolatum, USP purified water

Questions Or Comments?

1-888-287-1915

When Using This Product
  • avoid contact with eyes
  • do not use more than directed unless told to do so by a doctor
  • do not put directly into the rectum by using fingers or any mechanical device or applicator
Stop Use and Ask A Doctor If
  • condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
  • rectal bleeding occurs
Principal Display Panel 28 G Tube Carton

NDC 79903-092-01

equate™

Compare to

Cortisone•10®

Intensive

Healing Formula

active

ingredient*

MAXIMUM STRENGTH

Hydrocortisone

Cream 1%

Intensive Healing

Formula

Antipruritic (Anti-Itch)

With Antioxidants

Relieves Itch Fast

  • Rashes & Redness
  • Eczema & Psoriasis
  • Inflammation & Irritation
  • Dry, Itchy Skin

Contains Healing

Moisturizers Enriched

With Vitamin E

NET WT 1 OZ (28g)


Structured Label Content

Uses
  • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
    • eczema
    • psoriasis
    • poison ivy, oak, sumac
    • insect bites
    • detergents
    • jewelry
    • cosmetics
    • soaps
    • seborrheic dermatitis
  • temporarily relieves external anal and genital itching
  • other uses of this product should only be under the advice and supervision of a doctor
Section 42229-5 (42229-5)

Drug Facts

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 53414-9 (53414-9)

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

Purpose

Antipruritic (anti-itch)

Warnings

For external use only.

Directions
  • for itching of skin irritation, inflammation, and rashes:
    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: ask a doctor
  • for external anal and genital itching, adults:
    • when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
    • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
    • apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age: ask a doctor
Do Not Use (Do not use)
  • in the genital area if you have a vaginal discharge. Consult a doctor.
  • for the treatment of diaper rash. Consult a doctor.
Active Ingredient (Active ingredient)

Hydrocortisone 1%

Other Information (Other information)
  • store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.
Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf juice, ammonium acryloyldimethyltaurate/VP copolymer, bees wax, carbomer, ceteareth-6, cetyl alcohol, citric acid, coconut oil, corn starch, dimethicone, disodium EDTA, glycerin, isopropyl palmitate, methylparaben, mineral oil, propylene glycol, propylparaben, shea butter, sodium citrate, sodium lauryl sulfate, tocopheryl (vitamin E) acetate, white petrolatum, USP purified water

Questions Or Comments? (Questions or comments?)

1-888-287-1915

When Using This Product (When using this product)
  • avoid contact with eyes
  • do not use more than directed unless told to do so by a doctor
  • do not put directly into the rectum by using fingers or any mechanical device or applicator
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
  • rectal bleeding occurs
Principal Display Panel 28 G Tube Carton (PRINCIPAL DISPLAY PANEL - 28 g Tube Carton)

NDC 79903-092-01

equate™

Compare to

Cortisone•10®

Intensive

Healing Formula

active

ingredient*

MAXIMUM STRENGTH

Hydrocortisone

Cream 1%

Intensive Healing

Formula

Antipruritic (Anti-Itch)

With Antioxidants

Relieves Itch Fast

  • Rashes & Redness
  • Eczema & Psoriasis
  • Inflammation & Irritation
  • Dry, Itchy Skin

Contains Healing

Moisturizers Enriched

With Vitamin E

NET WT 1 OZ (28g)


Advanced Ingredient Data


Raw Label Data

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