Label: HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 61312-008-01, 61312-008-02 - Packager: Hangzhou Guoguang Touring Commodity Co., Ltd.
- 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 6, 2018
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61312-008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 63 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CARBOMER 940 (UNII: 4Q93RCW27E) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) TRIETHANOLAMINE SULFATE (UNII: MV1V89M17O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61312-008-01 24 in 1 CARTON 10/23/2016 1 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:61312-008-02 24 in 1 CARTON 10/23/2016 2 149.31 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 03/30/2013 Labeler - Hangzhou Guoguang Touring Commodity Co., Ltd. (526890634) Establishment Name Address ID/FEI Business Operations Hangzhou Guoguang Touring Commodity Co., Ltd. 526890634 manufacture(61312-008)