Label: COLLOIDAL OATMEAL cream
- NDC Code(s): 79481-9965-1, 79481-9965-2
- Packager: MEIJER
- 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 April 20, 2023
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- Active ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
- Directions
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
COLLOIDAL OATMEAL
colloidal oatmeal creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79481-9965 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 10 mg 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 KERNEL OIL (UNII: 3UVP41R77R) STEARETH-20 (UNII: L0Q8IK9E08) OAT (UNII: Z6J799EAJK) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) CERAMIDE 3 (UNII: 4370DF050B) SODIUM CHLORIDE (UNII: 451W47IQ8X) BENZYL ALCOHOL (UNII: LKG8494WBH) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79481-9965-2 141 g in 1 TUBE; Type 0: Not a Combination Product 06/24/2020 2 NDC:79481-9965-1 207 g in 1 TUBE; Type 0: Not a Combination Product 06/24/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 06/24/2020 Labeler - MEIJER (006959555) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(79481-9965) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(79481-9965)