71927-031 American Safety & First Aid

71927-031 American Safety & First Aid
SPL v2
SPL
SPL Set ID 4a543f90-d43c-4487-b27e-f43394c6320d
Route
TOPICAL
Published
Effective Date 2025-12-11
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 Ethylhexylglycerin Phenoxyethanol Glycerin Mineral Oil Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-11
Description

Hydrocortisone 1%

Purpose

Anti-Itch Cream

Medication Information

Purpose

Anti-Itch Cream

Description

Hydrocortisone 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
Section 51945-4

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 1%

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
Section 51945-4 (51945-4)

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 1%

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: 2026-02-15T12:08:05.920033 · Updated: 2026-03-14T23:12:14.139281