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, Nantong Health & Beyond Hygienic Products 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AMERICAN SAFETY AND FIRST AID 
hydrocortisone acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71927-031
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)
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: 71927-031-02	25 in 1 BOX	12/11/2025
1	NDC: 71927-031-01	0.9 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 71927-031-03	144 in 1 BOX	12/11/2025
2	NDC: 71927-031-01	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	12/11/2025

Labeler - Orazen Inc (080916640)

Registrant - Nantong Health & Beyond Hygienic Products Inc. (421280161)

Establishment
Name	Address	ID/FEI	Business Operations
Nantong Health & Beyond Hygienic Products Inc.		421280161	manufacture(71927-031)