Label: ANTIBACTERIAL- benzethonium chloride liquid
- NDC Code(s): 68599-5501-1, 68599-5501-2, 68599-5501-3, 68599-5501-4
- Packager: McKesson
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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Drug Label Information
Updated September 21, 2020
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANTIBACTERIAL
benzethonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68599-5501 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 0.13 g in 100 mL Inactive Ingredients Ingredient Name Strength SALICYLIC ACID (UNII: O414PZ4LPZ) SORBIC ACID (UNII: X045WJ989B) EDETATE SODIUM (UNII: MP1J8420LU) COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK) PEG-200 GLYCERYL STEARATE (UNII: Z8ROG2A0LZ) BENZYL ALCOHOL (UNII: LKG8494WBH) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) WATER (UNII: 059QF0KO0R) COCO MONOETHANOLAMIDE (UNII: C80684146D) GLYCERIN (UNII: PDC6A3C0OX) CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 4 (UNII: X3W0AM1JLX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68599-5501-1 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/29/2017 2 NDC:68599-5501-2 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/29/2017 3 NDC:68599-5501-3 237 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 09/29/2017 4 NDC:68599-5501-4 532 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 09/29/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/29/2017 Labeler - McKesson (023904428) Establishment Name Address ID/FEI Business Operations Central Solutions 007118524 manufacture(68599-5501)