Label: ZYTEC GERM BUSTER HAND SANITIZER- ethanol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 50021-065-01, 50021-065-02, 50021-065-03, 50021-065-04, view more50021-065-05, 50021-065-06, 50021-065-07 - Packager: Empack
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 January 28, 2011
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INGREDIENTS AND APPEARANCE
ZYTEC GERM BUSTER HAND SANITIZER
ethanol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50021-065 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ETHANOL (UNII: 3K9958V90M) (ETHANOL - UNII:3K9958V90M) ETHANOL 143 g in 238 g Inactive Ingredients Ingredient Name Strength CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) WATER (UNII: 059QF0KO0R) ISOPROPYL ALCOHOL (UNII: ND2M416302) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) POLYSORBATE 20 (UNII: 7T1F30V5YH) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50021-065-01 238 g in 1 BOTTLE, PUMP 2 NDC:50021-065-02 52 g in 1 BOTTLE, PLASTIC 3 NDC:50021-065-03 104 g in 1 BOTTLE, PLASTIC 4 NDC:50021-065-04 908 g in 1 BOTTLE, PUMP 5 NDC:50021-065-05 475 g in 1 BOTTLE, PUMP 6 NDC:50021-065-06 713 g in 1 BOTTLE, PUMP 7 NDC:50021-065-07 908 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/28/2011 Labeler - Empack (252047519) Registrant - Empack (252047519) Establishment Name Address ID/FEI Business Operations Empack 252047519 manufacture