Label: INDIVIDUAL FREE AND CLEAR FOAMING ANTIBACTERIAL SKIN CLEANSER- benzalkonium chloride soap
- NDC Code(s): 79258-751-29
- Packager: Brady Industries Inc.
- 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 14, 2022
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- Active ingredient
- Uses
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- Directions
- Inactive Ingredients
- Purpose
- Keep out of reach of children
- Label
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INGREDIENTS AND APPEARANCE
INDIVIDUAL FREE AND CLEAR FOAMING ANTIBACTERIAL SKIN CLEANSER
benzalkonium chloride soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79258-751 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) ALOE VERA LEAF (UNII: ZY81Z83H0X) FD&C RED NO. 40 (UNII: WZB9127XOA) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) WATER (UNII: 059QF0KO0R) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79258-751-29 1000 mL in 1 BAG; Type 0: Not a Combination Product 03/02/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 03/02/2022 Labeler - Brady Industries Inc. (034932657) Registrant - Betco Corporation (005050158) Establishment Name Address ID/FEI Business Operations Betco Corporation 005050158 manufacture(79258-751) , label(79258-751) , analysis(79258-751) , pack(79258-751)