NDC | 50382-012-01 |
Set ID | 987f3500-e7b4-45bc-bb29-8b5b59b9bb4b |
Category | HUMAN OTC DRUG LABEL |
Packager | Galentic Pharma (India) Private Limited |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART347 |
- 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
- Principal Display Panel
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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)