UNISHIELD 1%- hydrocortisone cream 
Unishield

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49314-0005 Unishield Hydrocortisone

Active ingredient

Hydrocortisone 1%

Purpose  Anti-itch

Uses

Warnings

For external use only.

Do not use

When using this product:

Stop use and ask a doctor if 

condition worsens or lasts more than 7 days, or clears and occurs again within a few days

you begin use of other hydrocortisone product unless you have consulted a doctor

bleeding occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions 

Other information

Inactive ingredients

cetearyl alcohol, ceteareth-20, ethylhexylglycerin, glycerin, glycerol fatty acid ester, mineral oil, petrolactum, phenoxyethanol, water

image description

UNISHIELD 1% 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49314-0005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49314-0005-125 in 1 BOX11/15/2023
10.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01711/15/2023
Labeler - Unishield (790677053)
Establishment
NameAddressID/FEIBusiness Operations
Nantong Health & Beyond Hygienic Products Inc.421280161manufacture(49314-0005)

Revised: 11/2023
Document Id: 0a3a836a-a193-b951-e063-6294a90a182d
Set id: 4871a67f-fbb8-4a6b-ace4-d34349028908
Version: 1
Effective Time: 20231115
 
Unishield