AMERICAN SAFETY AND FIRST AID- hydrocortisone acetate cream

American Safety and First Aid by

Drug Labeling and Warnings

American Safety and First Aid by is a Otc medication manufactured, distributed, or labeled by Orazen Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Package Labeling:

INGREDIENTS AND APPEARANCE

AMERICAN SAFETY AND FIRST AID 
hydrocortisone acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71927-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERIN (UNII: PDC6A3C0OX)
MINERAL OIL (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71927-015-02	25 in 1 BOX	10/17/2022
1	NDC: 71927-015-01	0.9 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	10/17/2022

Labeler - Orazen Inc (080916640)