71927-015 American Safety & First Aid

71927-015 American Safety & First Aid
SPL v2
SPL
SPL Set ID eb0cfde0-c463-e9b5-e053-2a95a90a1924
Route
TOPICAL
Published
Effective Date 2022-10-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Petrolatum Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol Glyceryl 1-stearate Ethylhexylglycerin Phenoxyethanol Glycerin Mineral Oil Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-17
Description

Hydrocortisone Acetate 1%

Purpose

Anti-Itch Cream

Medication Information

Purpose

Anti-Itch Cream

Description

Hydrocortisone Acetate 1%

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

Warnings

For external use only

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
Do Not Use

for the treatment of diaper rash. Consult a doctor. Complete Warnings See Card or Box

Drug Facts

Active Ingredient

Hydrocortisone Acetate 1%

Package Labeling:

Inactive Ingredients

Cetearyl alcohol, Ceteareth-20, Ethylhexyglycerin,Phenoxyethanol, Glycerin, Glycerol fatty acid ester, Mineral Oil, Petrolatum, Water

Keep Out of Reach of Children.

If swallowed contact a Poison Control Center right away.

Structured Label Content

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

Purpose

Anti-Itch Cream

Warnings

For external use only

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
Do Not Use (Do not use)

for the treatment of diaper rash. Consult a doctor. Complete Warnings See Card or Box

Drug Facts

Active Ingredient

Hydrocortisone Acetate 1%

Package Labeling:

Inactive Ingredients

Cetearyl alcohol, Ceteareth-20, Ethylhexyglycerin,Phenoxyethanol, Glycerin, Glycerol fatty acid ester, Mineral Oil, Petrolatum, Water

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:42.462319 · Updated: 2026-03-14T23:02:24.469183