Label: WET WIPES ANTIBACTERIAL HAND WIPES- benzethonium chloride swab
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Contains inactivated NDC Code(s)
NDC Code(s): 77125-003-01 - Packager: Ningbo Yinzhou GreenLight 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
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INGREDIENTS AND APPEARANCE
WET WIPES ANTIBACTERIAL HAND WIPES
benzethonium chloride swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77125-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 0.45 g in 150 g Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) 0.0045 g in 150 g ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.15 g in 150 g METHYLPARABEN (UNII: A2I8C7HI9T) 0.0165 g in 150 g PROPYLPARABEN (UNII: Z8IX2SC1OH) 0.0045 g in 150 g WATER (UNII: 059QF0KO0R) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) 0.0045 g in 150 g GLYCERIN (UNII: PDC6A3C0OX) 0.15 g in 150 g PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.15 g in 150 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77125-003-01 150 g in 1 BAG; 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 GreenLight 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(77125-003) Establishment Name Address ID/FEI Business Operations NINGHAI WEIYI DAYLY NECESSITIES FACTORY 554532482 manufacture(77125-003) , pack(77125-003) , label(77125-003)