Label: WALGREENS BABY ECZEMA- colloidal oatmeal cream
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Contains inactivated NDC Code(s)
NDC Code(s): 0363-3550-05 - Packager: Walgreen Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 November 29, 2017
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INGREDIENTS AND APPEARANCE
WALGREENS BABY ECZEMA
colloidal oatmeal creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-3550 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 0.01 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) PETROLATUM (UNII: 4T6H12BN9U) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) CETYL ALCOHOL (UNII: 936JST6JCN) PANTHENOL (UNII: WV9CM0O67Z) DIMETHICONE (UNII: 92RU3N3Y1O) OAT (UNII: Z6J799EAJK) STEARETH-20 (UNII: L0Q8IK9E08) OAT KERNEL OIL (UNII: 3UVP41R77R) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) ISOCETYL ALCOHOL (UNII: 1800H64066) CERAMIDE NP (UNII: 4370DF050B) SODIUM CHLORIDE (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-3550-05 142 g in 1 TUBE; Type 0: Not a Combination Product 11/28/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 11/28/2017 Labeler - Walgreen Company (008965063) Registrant - Apollo Health and Beauty Care Inc. (201901209) Establishment Name Address ID/FEI Business Operations Apollo Health and Beauty Care Inc. 201901209 manufacture(0363-3550)