Label: ANTIBACTERIAL HAND SANITIZER liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 78634-002-01 - Packager: Dongguan Boze Technology 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 17, 2020
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
- Warnings
- When using this product
- Keep out of reach of children
- Directions
- Inactive ingredients
- Other information
- Package Label
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INGREDIENTS AND APPEARANCE
ANTIBACTERIAL HAND SANITIZER
antibacterial hand sanitizer liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78634-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 75.15 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.4 mL in 100 mL PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.16 mL in 100 mL WATER (UNII: 059QF0KO0R) 23.905 mL in 100 mL CUPRIC TRIETHANOLAMINE (UNII: 6NU949U74E) 0.3 mL in 100 mL POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) 0.085 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78634-002-01 10 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/17/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/17/2020 Labeler - Dongguan Boze Technology Co., LTD (554535587) Registrant - Dongguan Boze Technology Co., LTD (554535587) Establishment Name Address ID/FEI Business Operations Dongguan Boze Technology Co., LTD 554535587 manufacture(78634-002)
