American Safety And First Aid Cream
FDA Label NDC 71927-031

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Orazen Inc for the product American Safety And First Aid (NDC 71927-031). 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 drug facts, active ingredient, purpose, uses, warnings, do not use, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Hydrocortisone Acetate 1%

Purpose

Anti-Itch Cream

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

Do Not Use

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

Keep Out Of Reach Of Children.

If swallowed contact a Poison Control Center right away.

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

Inactive Ingredients

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

* Please review the disclaimer below.