SHOPKO HYDROCORTISONE- hydrocortisone cream

SHOPKO HYDROCORTISONE by

Drug Labeling and Warnings

SHOPKO HYDROCORTISONE by is a Otc medication manufactured, distributed, or labeled by UNITED EXCHANGE CORP., TAI GUK PHARM. CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                                                                                      Purpose

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

PURPOSE

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

• eczema
• seborrheic dematitis
• psoriasis
• insect bites
• poison ivy, oak, sumac
• soaps
• detergents
• cosmetics
• jewelry
• external genital, feminine and anal itching
  

WHEN USING

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

Warnings

• for external use only
• avoid contact with eyes
  

STOP USE

Stop using this product and ask a doctor

• if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
• before you begin using any other hydrocortisone product
  

ASK DOCTOR

Do not use this product and ask a doctor

• if you have a vaginal discharge
• before treating diaper rash
• before using on children under 2 years of age
  

KEEP OUT OF REACH OF CHILDREN

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.

INDICATIONS & USAGE

Directions

• for 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, consult a doctor
  

SAFE HANDLING WARNING

Other information

• store at room temperature
• Lot No. and Exp. Date: see box or see crimp of tube
  

INACTIVE INGREDIENT

Inactive ingredients

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

DOSAGE & ADMINISTRATION

Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703

www.ueccorp.com

Made in Korea

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

SHOPKO HYDROCORTISONE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55264-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55264-001-86	1 in 1 CARTON
1		28 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/08/2011

Labeler - UNITED EXCHANGE CORP. (840130579)

Registrant - UNITED EXCHANGE CORP. (840130579)

Establishment
Name	Address	ID/FEI	Business Operations
TAI GUK PHARM. CO., LTD.		631101656	manufacture