HYDROCORTISONE- hydrocortisone cream 
Nantong Health & Beyond Hygienic Products Inc.

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43473-049-01_Hydrocortisone

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

Warnings

For external use only.

Avoid contact with the eyes.

Do not use

for the treatment of diaper rash. Consult a doctor.

Do not use, consult a doctor

if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.

Do not use if the packaging is broken

Keep out of reach of children.

If swallowed contact a Poison Control Center right away.

Directions

Inactive ingredients

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

Package Labeling:

Label

HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43473-049
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43473-049-010.9 g in 1 PACKET; Type 0: Not a Combination Product08/08/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01708/08/2024
Labeler - Nantong Health & Beyond Hygienic Products Inc. (421280161)
Registrant - Nantong Health & Beyond Hygienic Products Inc. (421280161)
Establishment
NameAddressID/FEIBusiness Operations
Nantong Health & Beyond Hygienic Products Inc.421280161manufacture(43473-049)

Revised: 8/2024
Document Id: 1f390f4e-6459-89ef-e063-6294a90a33ed
Set id: fbbbcc67-b46d-d41a-e053-6294a90aa55d
Version: 3
Effective Time: 20240808
 
Nantong Health & Beyond Hygienic Products Inc.