Label: ANTIBACTERIAL WIPES- benzethonium chloride swab
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NDC Code(s):
70031-001-01,
70031-001-02,
70031-001-03,
70031-001-04, view more70031-001-06
- Packager: TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY
- 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 March 19, 2022
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- Active ingredient
- Use
- Warnings
- Directions
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANTIBACTERIAL WIPES
benzethonium chloride swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70031-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 0.3 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETIC ACID (UNII: 9G34HU7RV0) ALCOHOL (UNII: 3K9958V90M) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) POTASSIUM BENZOATE (UNII: 763YQN2K7K) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70031-001-01 12 in 1 BAG 01/08/2018 1 0.0108 g in 1 POUCH; Type 0: Not a Combination Product 2 NDC:70031-001-02 1 in 1 BAG 01/08/2018 2 0.0108 g in 1 POUCH; Type 0: Not a Combination Product 3 NDC:70031-001-03 1 in 1 BOTTLE, PLASTIC 01/08/2018 3 0.0108 g in 1 POUCH; Type 0: Not a Combination Product 4 NDC:70031-001-04 5 in 1 BAG 01/08/2018 4 0.0108 g in 1 POUCH; Type 0: Not a Combination Product 5 NDC:70031-001-06 6 in 1 BAG 01/08/2018 5 0.0108 g in 1 POUCH; 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 part333A 08/05/2015 Labeler - TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY (679914791) Registrant - TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY (679914791) Establishment Name Address ID/FEI Business Operations TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY 679914791 manufacture(70031-001)