Equate Hydrocortione Cream
FDA Label NDC 79903-211

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 Inc. for the product Equate Hydrocortione (NDC 79903-211). 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 drug fact, active ingredient, purpose, uses, do not use, when using this product, stop use and ask a doctor if, keep out of the reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Fact

Active Ingredient

Hydrocortisone Acetate 1%

Purpose

Anti itch 

Uses

For temporarily relief of 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

Other uses of this product should only be under the advice and supervision of a doctor

Do Not Use

  •  for the treatment of diaper rash. Consult a doctor.
  • for external genital itching if you have a vaginal discharge, consult a doctor. 

When Using This Product

  • Avoid contact with the eyes
  • Do not begin the use of any other hydrocortisone products unless you have consulted a doctor. 
  • For genital, feminine and anal itching do not exceed the recommended daily dose unless directed by a doctor, in case of bleeding , stop use and consult a doctor
  • Do not put this product 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

Keep Out Of The Reach Of Children

If swallowed get medical help or contact a poison control center (1-800-222-1222) right away. 

Directions

  • 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: do not use, ask a doctor
  • For external anal itching ; adults ; when practical cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product.Children under 12 years of age with external anal itching consult a doctor. 

Other Information

store at a controlled room temperature 20-25°C (68-77 F)

Inactive Ingredients

Cetearyl Alcohol, Petrolatum, Phenoxyethanol, Propylene Glycol, Sodium Lauryl Sulfate, Water (purified)

Principal  Display Panel 1 Oz

Equate          NDC 79903-211-01

Maximum Strength

Hydrocortisone Cream 1%

Paraben free/Anti-itch

NETWT 1 OZ ( 28g)

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