Label: ZINC OXIDE AND DIMETHICONE WITH DIMETHICONE- zinc oxide and dimethicone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 50382-012-01 - Packager: Galentic Pharma (India) Private Limited
- 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 August 9, 2013
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- ACTIVE INGREDIENT
- Purpose:
- Warnings:
- Dosage and Administration:
- Other information
- Inactive ingredients
- Stop use if
- Indications and Usage
- Do not use
- Keep out of reach of children
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INGREDIENTS AND APPEARANCE
ZINC OXIDE AND DIMETHICONE WITH DIMETHICONE
zinc oxide and dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50382-012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 200 mg in 1 g DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 18 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) CETYL ALCOHOL (UNII: 936JST6JCN) CHOLECALCIFEROL (UNII: 1C6V77QF41) LANOLIN (UNII: 7EV65EAW6H) METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) WATER (UNII: 059QF0KO0R) CETETH-10 (UNII: LF9X1PN3XJ) PARAFFIN (UNII: I9O0E3H2ZE) PROPYLPARABEN SODIUM (UNII: 625NNB0G9N) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) STEARETH-20 (UNII: L0Q8IK9E08) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) POLYSORBATE 60 (UNII: CAL22UVI4M) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) VITAMIN A (UNII: 81G40H8B0T) ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50382-012-01 113.4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 08/08/2013 Labeler - Galentic Pharma (India) Private Limited (918531450)