Label: OATMEAL- dimethicone lotion
- NDC Code(s): 76176-063-01
- Packager: NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., 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 October 24, 2022
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- Official Label (Printer Friendly)
- oatmeal and cream
- Active Ingredient
- Purpose
- Uses:
- Directions:
- Warning:
- KEEP OUT OF REACH OF CHILDREN
- STOP USE
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Inactive Ingredients:
Water (Aqua), Mineral Oil, Getearyl Alcohol, Glycerin, Glyceryl Stearate, Petrolatum, Ceteareth-20, Propylene Glycol, Carbomer, Triethanolamine, Avena Stiva (OAT) Kernel Flour, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, DMDM Hydantoin, Dichlorobenzyl Alcohol, Iodopropynyl Butylcarbamate, FD&C Yellow No.5, FD&C Red No. 40.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OATMEAL
dimethicone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76176-063 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 1 g in 100 g Inactive Ingredients Ingredient Name Strength .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947) CETEARETH-22 (UNII: 28VZG1E234) MINERAL OIL (UNII: T5L8T28FGP) CUPRIC BIS(TRIETHANOLAMINE) (UNII: YBM44X0B6H) PETROLATUM (UNII: 4T6H12BN9U) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CARBOMER 934 (UNII: Z135WT9208) AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG) DICHLOROBENZYL ALCOHOL (UNII: 1NKX3648J9) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) ALOE VERA LEAF (UNII: ZY81Z83H0X) DMDM HYDANTOIN (UNII: BYR0546TOW) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76176-063-01 354 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 04/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 04/01/2019 Labeler - NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD (530766098) Registrant - NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD (530766098) Establishment Name Address ID/FEI Business Operations NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD 530766098 manufacture(76176-063)