Label: APPLE SCENTED HAND SANITIZER 01- benzalkonium chloride gel
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Contains inactivated NDC Code(s)
NDC Code(s): 77901-013-01 - Packager: Foshan Astar Industry 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 July 7, 2021
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INGREDIENTS AND APPEARANCE
APPLE SCENTED HAND SANITIZER 01
benzalkonium chloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77901-013 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 mL Inactive Ingredients Ingredient Name Strength COCETH-7 (UNII: 58Y261JLH5) 0.68 mL in 100 mL PPG-1-PEG-9 LAURYL GLYCOL ETHER (UNII: 5R8J43K25L) 0.68 mL in 100 mL WATER O-18 (UNII: 7QV8F8BYNJ) 96 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 1.5 mL in 100 mL CARBOMER 934 (UNII: Z135WT9208) 0.24 mL in 100 mL SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.12 mL in 100 mL HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) 0.15 mL in 100 mL FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.005 g in 100 mL APPLE (UNII: B423VGH5S9) 0.3 mL in 100 mL FD&C RED NO. 40 (UNII: WZB9127XOA) 0.003 g in 100 mL Product Characteristics Color orange Score Shape Size Flavor APPLE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77901-013-01 59 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package 06/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/30/2020 Labeler - Foshan Astar Industry Co., Ltd (421358695) Registrant - Foshan Astar Industry Co., Ltd (421358695) Establishment Name Address ID/FEI Business Operations Foshan Astar Industry Co., Ltd 421358695 manufacture(77901-013)
