Label: CLEAN HANDS INSTANT HAND SANITIZER- benzalkonium chloride liquid
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NDC Code(s):
50254-457-10,
50254-457-12,
50254-457-13,
50254-457-17, view more50254-457-18, 50254-457-27
- Packager: Beaver Research Company
- Category: HUMAN OTC DRUG LABEL
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 7, 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
- Quick Defense Instant Hand Sanitizer
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INGREDIENTS AND APPEARANCE
CLEAN HANDS INSTANT HAND SANITIZER
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50254-457 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 WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) DMDM HYDANTOIN (UNII: BYR0546TOW) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50254-457-10 1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product 01/07/2020 2 NDC:50254-457-12 1000 mL in 1 BAG; Type 0: Not a Combination Product 01/07/2020 3 NDC:50254-457-13 800 mL in 1 BAG; Type 0: Not a Combination Product 01/07/2020 4 NDC:50254-457-18 50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/07/2020 5 NDC:50254-457-27 800 mL in 1 CARTRIDGE; Type 0: Not a Combination Product 01/07/2020 6 NDC:50254-457-17 532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/07/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 01/07/2020 Labeler - Beaver Research Company (044960466) Registrant - ABC Compounding Co., Inc. (003284353) Establishment Name Address ID/FEI Business Operations ABC Compounding Co., Inc. 003284353 manufacture(50254-457)