Label: HAND SANITIZER ANTIBACTERIAL- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 77125-002-01 - Packager: Ningbo Yinzhou Lvguang International Trade 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 May 6, 2020
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- Active Ingredient
- Uses
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- Inactive Ingredients
- Package Label
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INGREDIENTS AND APPEARANCE
HAND SANITIZER ANTIBACTERIAL
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77125-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 146.32 mL in 236 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) 2.36 mL in 236 mL FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.236 mL in 236 mL TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN) 2.36 mL in 236 mL TOCOPHEROL (UNII: R0ZB2556P8) 1.18 mL in 236 mL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.708 mL in 236 mL GLYCERIN (UNII: PDC6A3C0OX) 2.36 mL in 236 mL PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 2.36 mL in 236 mL WATER (UNII: 059QF0KO0R) 77.88 mL in 236 mL FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.236 mL in 236 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77125-002-01 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/06/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/06/2020 Labeler - Ningbo Yinzhou Lvguang International Trade Co.,Ltd (542990878) Registrant - NINGHAI WEIYI DAYLY NECESSITIES FACTORY (554532482) Establishment Name Address ID/FEI Business Operations Ningbo Yinzhou Lvguang International Trade Co.,Ltd 542990878 repack(77125-002) Establishment Name Address ID/FEI Business Operations NINGHAI WEIYI DAYLY NECESSITIES FACTORY 554532482 manufacture(77125-002) , label(77125-002) , pack(77125-002)
