Hydrocortisone Cream
FDA Label NDC 47682-397

13 label sections · Submitted to the FDA by Unifirst First Aid Corporation · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Unifirst First Aid Corporation for the product Hydrocortisone (NDC 47682-397). 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, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

Otc - Active Ingredient

Active ingredient

Hydrocortisone 1.0%

Otc - Purpose

Purpose

Anti itch

Warnings

Warnings

For external use only

Otc - Do Not Use

Do not use

  • for the treatment of diaper rash
  • in eyes
  • for feminine itching

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions

  • for adults and children (2 years of age and older): apply to affected area 3 to 4 times daily
  • children under 12 years of age: for external anal itching, consult a doctor
  • children under 2 years of age: do not use, consult a doctor
  • adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
  • gently dry by patting or botting with toilet tissue or a soft cloth before application of this product

Other Safety Information

Other information

  • store at room temperature (do not freeze)
  • tamper evident, do not use any opened or torn packets

Otc - Questions

Questions or comments?

1-800-869-6970

Inactive Ingredient

Inactive ingredient

emulsifying wax, ethanoll, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

* Please review the disclaimer below.