Hydrocortisone Cream
FDA Label NDC 47682-933

Full FDA labeling including 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 47682-933). 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 (in each gram), purpose, uses, warnings, do not use, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient (In Each Gram)

Hydrocortisone 1.0%

Purpose

Anti-itch

Uses

For the temporary relief of itching associated with minor skin irritation, inflammation and rashes. Other uses of this product should be only under advice and supervision of a doctor

Warnings

For external use only

Do Not Use

  • in the eyes
  • to treat a diaper rash
  • this or any other hydrocortisone product unless you have consulted a doctor

Stop Use And Ask A Doctor If

  • the condition gets worse
  • condition clears up and recurs within a few days
  • condition persists for more than 7 days

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.

Adults And Children 2 Years And Over:

  • apply to affected area not more than 3 to 4 times daily

Children Under 2 Years:

  • do not use, consult a doctor

Other Information

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

Inactive Ingredients

Emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

Principal Display Panel – 0.9G Pouch Label

1% HYDROCORTISONE CREAM

ANTI-ITCH CREAM

1/32oz. (0.9g)

Manufactured for Medique Products, Fort Myers, FL 33967 USA

Principal Display Panel – 25 Unit Box Label

MEDI-FIRST
Plus

Hydrocortisone Cream 1%

25 units of 1/32 oz (0.9g) Packets

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