Equate Hydrocortisone Cream
FDA Label NDC 79903-092

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walmart for the product Equate Hydrocortisone (NDC 79903-092). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel - 28 G Tube Carton

Other

Drug Facts

DISTRIBUTED BY: Walmart Inc.,
Bentonville, AR 72716

Active Ingredient

Hydrocortisone 1%

Purpose

Antipruritic (anti-itch)

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

Warnings

For external use only.

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.

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

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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

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

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