Label: OATMEAL- dimethicone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 46994-619-32 - Packager: Save A Lot Food Stores LTD
- 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 December 1, 2015
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- Official Label (Printer Friendly)
- claims
- Active ingredient
- Purpose
- use
- Warnings
- When using this product
- Stop use and ask a doctor if
- Do not use on
- Keep out of reach of children
- Directions
- Inactive ingredients
- Disclaimer
- Adverse Reactions
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
OATMEAL
dimethicone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46994-619 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 13 mg in 1 mL Inactive Ingredients Ingredient Name Strength OATMEAL (UNII: 8PI54V663Y) BENZYL ALCOHOL (UNII: LKG8494WBH) CETYL ALCOHOL (UNII: 936JST6JCN) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) PETROLATUM (UNII: 4T6H12BN9U) SODIUM CHLORIDE (UNII: 451W47IQ8X) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46994-619-32 354 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 11/20/2015 Labeler - Save A Lot Food Stores LTD (095484572) Registrant - Vi Jon (790752542) Establishment Name Address ID/FEI Business Operations Vi Jon 790752542 manufacture(46994-619)