Label: ANTIBACTERIAL WET WIPES- benzalkonium chloride swab
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Contains inactivated NDC Code(s)
NDC Code(s): 50672-838-01 - Packager: MC Group Development 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 November 12, 2012
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- Active Ingredient
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- WARNINGS
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- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANTIBACTERIAL WET WIPES
benzalkonium chloride swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50672-838 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 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Iodopropynyl Butylcarbamate (UNII: 603P14DHEB) DMDM Hydantoin (UNII: BYR0546TOW) Lauryl Glucoside (UNII: 76LN7P7UCU) GLYCERIN (UNII: PDC6A3C0OX) DEXPANTHENOL (UNII: 1O6C93RI7Z) TOCOPHERYL NICOTINATE, D-.ALPHA. (UNII: WI1J5UCY5C) MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) DISODIUM EDTA-COPPER (UNII: 6V475AX06U) ALOE VERA LEAF (UNII: ZY81Z83H0X) Allantoin (UNII: 344S277G0Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50672-838-01 3.3 g in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/12/2012 Labeler - MC Group Development Ltd. (527868588) Establishment Name Address ID/FEI Business Operations MC Group Development Ltd. 527868588 manufacture(50672-838)