Hydrocortisone Cream
FDA Label NDC 47682-933

12 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 47682-933). 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, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Other information

  • clean the affected area
  • store at room temperature (do not freeze)
  • tamper evident, do notany opened or torn packets
  • you may report a serious adverswe reaction to this product to 800-634-7680

Otc - Active Ingredient

Active ingredient

Hydrocortisone 1.0%

Indications & Usage

Uses

  • for the temporary relief of itching associated with minor skin irritations, inflammation and rashes
  • other uses of this product should be only under the advice and supervision of a doctor

Warnings

Warnings

For external use only

Otc - Do Not Use

Do not use

  • for the teatment of diaper rash. Consult a doctor

Otc - Stop Use

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occurs again within a few 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.

Dosage & Administration

Directions

  • adults and children 2 years of age and over: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: do not use, consult a doctor

Inactive Ingredients

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

Medi-First Plus Hydrocortisone

MEDI-FIRST®
Plus

Hydrocortisone Cream 1%

Temporary relief of itching associated with monor skin irritations, inflamation and rashes

25 units / Net Wt 0.9 g ( 1/32 oz)

Item #93373

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