Label: ANTIBACTERIAL HAND SANITIZER- benzalkonium chloride gel
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Contains inactivated NDC Code(s)
NDC Code(s): 61312-007-01 - 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
ANTIBACTERIAL HAND SANITIZER
benzalkonium chloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61312-007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.1 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) SODIUM CHLORIDE (UNII: 451W47IQ8X) DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M) COCAMIDE (UNII: 3YXD33R71G) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERYL COCOATE (UNII: WVK1CT5994) CITRIC ACID ACETATE (UNII: DSO12WL7AU) DISODIUM EDTA-COPPER (UNII: 6V475AX06U) TOCOPHERYL RETINOATE (UNII: 0WN694NBMM) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61312-007-01 24 in 1 CARTON 10/23/2016 1 221 g in 1 BOTTLE; 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 02/27/2014 Labeler - Hangzhou Guoguang Touring Commodity Co., Ltd. (526890634) Establishment Name Address ID/FEI Business Operations Hangzhou Guoguang Touring Commodity Co., Ltd. 526890634 manufacture(61312-007)