Label: BORTEK ANTIBACTERIAL HAND WASH- chloroxylenol liquid
- NDC Code(s): 81731-508-10, 81731-508-11
- Packager: Bortek Industries
- 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 September 26, 2022
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- INACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
BORTEK ANTIBACTERIAL HAND WASH
chloroxylenol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81731-508 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 0.3 g in 100 mL Inactive Ingredients Ingredient Name Strength PHENOXYETHANOL (UNII: HIE492ZZ3T) FD&C RED NO. 4 (UNII: X3W0AM1JLX) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) COCO DIETHANOLAMIDE (UNII: 92005F972D) DMDM HYDANTOIN (UNII: BYR0546TOW) ALCOHOL (UNII: 3K9958V90M) ISOPROPYL ALCOHOL (UNII: ND2M416302) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81731-508-10 1000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 04/12/2021 02/19/2022 2 NDC:81731-508-11 1000 mL in 1 POUCH; Type 0: Not a Combination Product 02/19/2022 07/20/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 04/12/2021 07/20/2024 Labeler - Bortek Industries (014184014)