Label: FOAMING INSTANT HAND SANITIZER- benzethonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 72234-575-10, 72234-575-12, 72234-575-14, 72234-575-18 - Packager: Pro Source Distributors, 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 January 17, 2020
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- Drug Facts Box OTC-Active Ingredient Section
- Drug Facts Box OTC-Indications & Usage Section
- Drug Facts Box OTC-Warnings Section
- Drug Facts Box OTC-Purpose Section
- Drug Facts Box-OTC When Using Section
- Drug Facts Box-OTC Stop Use Section
- Drug Facts Box-OTC Keep Out Of Reach Of Children Section
- Drug Facts Box-OTC Dosage & Administration Section
- Drug Facts Box-OTC Inactive Ingredient Section
- Foaming Instant Hand Sanitizer 6575 Drug Facts and Label
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INGREDIENTS AND APPEARANCE
FOAMING INSTANT HAND SANITIZER
benzethonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72234-575 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 2 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) DMDM HYDANTOIN (UNII: BYR0546TOW) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72234-575-10 1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product 05/29/2018 2 NDC:72234-575-18 50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/29/2018 3 NDC:72234-575-14 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/29/2018 4 NDC:72234-575-12 1000 mL in 1 BAG; Type 0: Not a Combination Product 05/29/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 05/29/2018 Labeler - Pro Source Distributors, Inc. (837372085) Registrant - ABC Compounding Co., Inc. (003284353) Establishment Name Address ID/FEI Business Operations ABC Compounding Co., Inc. 003284353 manufacture(72234-575)
