SHOPKO HYDROCORTISONE - hydrocortisone cream 
UNITED EXCHANGE CORP.

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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Drug Fact

Active Ingredient                                                                                      Purpose

Hydrocortisone 1% .................................................................................Anti-itch

Uses  for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to:

Other uses or the use of this product for more than 7 days should be undertaken only under the advice and supervision of a doctor

Warnings

Stop using this product and ask a doctor

Do not use this product and ask a doctor

Keep this and all drugs out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Before using any medication, read all label directions.  Keep this carton.  It contains important information.

Directions

Other information

Inactive ingredients

glycerin, propylene glycol, sodium chloride, white petrolatum, cetyl alcohol, dimethicone, isopropyl palmitate, distearyldimonium chloride, methylparaben, propylparaben, purified water

Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703

www.ueccorp.com

Made in Korea

image of carton labelEnter section text here

SHOPKO HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55264-001
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
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PETROLATUM (UNII: 4T6H12BN9U)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55264-001-861 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/08/2011
Labeler - UNITED EXCHANGE CORP. (840130579)
Registrant - UNITED EXCHANGE CORP. (840130579)
Establishment
NameAddressID/FEIBusiness Operations
TAI GUK PHARM. CO., LTD.631101656manufacture

Revised: 2/2011
Document Id: a2835b9e-fe09-4698-b0e2-141706449d40
Set id: 3884ad95-9f20-4411-825b-00cb8fcc2f75
Version: 1
Effective Time: 20110208
 
UNITED EXCHANGE CORP.