Label: 99 PLUS HAND SANITIZER- benzealkonium chloride liquid
- NDC Code(s): 63533-457-10, 63533-457-12, 63533-457-14, 63533-457-18
- Packager: Momar Incorporated
- 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 June 28, 2019
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- Drug Facts Box OTC-Active Ingredient Section
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- 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
- 99 Plus Instant Hand Sanitizer
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INGREDIENTS AND APPEARANCE
99 PLUS HAND SANITIZER
benzealkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63533-457 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:63533-457-10 1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product 06/28/2019 2 NDC:63533-457-18 50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/28/2019 3 NDC:63533-457-14 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/28/2019 4 NDC:63533-457-12 1000 mL in 1 BAG; Type 0: Not a Combination Product 06/28/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 06/28/2019 Labeler - Momar Incorporated (003266616) Registrant - ABC Compounding Co., Inc. (003284353) Establishment Name Address ID/FEI Business Operations ABC Compounding Co., Inc. 003284353 manufacture(63533-457)
