HYDROCORTISONE- hydrocortisone cream 
UniShield

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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HYDROCORTISONE CREAM

Drug Facts

Warnings

For external use only

Do not use

Stop use, as a doctor

Keep out of reach of children.

If ingested, contact a Poison Control Center right away

Directions

Inactive ingredients

Emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

ACTIVE INGREDIENT

Hydrocortisone 1.0%

USES:

For temporary relief of itching associated with minor skin irritations, inflammation or rashes. Other uses of product should be only under the advice and supervision of a doctor.

PRINCIPLE DISPLAY PANEL

HYDROCORTISONE CREAM

1/32 oz. (0.9g)

Dist by:UniShield

San Fernando, CA 91340

ACTIVE INGREDIENT

Hydrocortisone 1.0%

USES: For temporary relief

of itching associated with

minor skin irritations, inflammation or rashes.

Other uses of product

should be only under

the advice and supervision

of a doctor.

PRINCIPLE DISPLAY PANEL
HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49314-5801
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
alcohol (UNII: 3K9958V90M)  
methylparaben (UNII: A2I8C7HI9T)  
mineral oil (UNII: T5L8T28FGP)  
paraffin (UNII: I9O0E3H2ZE)  
petrolatum (UNII: 4T6H12BN9U)  
propylparaben (UNII: Z8IX2SC1OH)  
water (UNII: 059QF0KO0R)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
polysorbate 60 (UNII: CAL22UVI4M)  
PEG-150 distearate (UNII: 6F36Q0I0AC)  
steareth-20 (UNII: L0Q8IK9E08)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49314-5801-00.8 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34807/28/2010
Labeler - UniShield (790677053)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE

Revised: 7/2010
Document Id: ce039b46-d1d2-40bf-9a2c-d5c177793fb2
Set id: 97caf1c9-1159-40f9-aa2a-a9be6cc2563d
Version: 1
Effective Time: 20100728
 
UniShield