Label: SHOPKO HYDROCORTISONE- hydrocortisone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 55264-001-86 - Packager: UNITED EXCHANGE CORP.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated February 8, 2011
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- ACTIVE INGREDIENT
- PURPOSE
- WHEN USING
- WARNINGS
- STOP USE
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- SAFE HANDLING WARNING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SHOPKO HYDROCORTISONE
hydrocortisone creamProduct 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