AMERICAN SAFETY AND FIRST AID- hydrocortisone acetate cream 
Orazen Inc

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71927-015 American Safety & First Aid
Hydrocortisone Cream 1%

Drug Facts

Active Ingredient

Hydrocortisone Acetate 1%

Purpose

Anti-Itch Cream

Uses

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

Inactive Ingredients

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

Package Labeling:

image of pouch labelimage of box label

AMERICAN SAFETY AND FIRST AID 
hydrocortisone acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71927-015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71927-015-0225 in 1 BOX10/17/2022
1NDC:71927-015-010.9 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01710/17/2022
Labeler - Orazen Inc (080916640)

Revised: 1/2024
Document Id: 0efffe79-6b2c-8272-e063-6294a90a8f5a
Set id: eb0cce4b-c70a-1b2d-e053-2995a90aa4aa
Version: 2
Effective Time: 20240115
 
Orazen Inc