Label: HANDS FIRST TM- benzalkonium chloride solution
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Contains inactivated NDC Code(s)
NDC Code(s): 81858-021-01, 81858-021-02, 81858-021-04, 81858-021-06, view more81858-021-08, 81858-021-12, 81858-021-16, 81858-021-32, 81858-021-64 - Packager: Hands First, LLC.
- 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 May 7, 2021
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INGREDIENTS AND APPEARANCE
HANDS FIRST TM
benzalkonium chloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81858-021 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) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) ALLANTOIN (UNII: 344S277G0Z) GLYCOLIC ACID (UNII: 0WT12SX38S) DIMETHICONE (UNII: 92RU3N3Y1O) ALOE VERA LEAF (UNII: ZY81Z83H0X) SILVER (UNII: 3M4G523W1G) ENGLISH LAVENDER OIL (UNII: ZBP1YXW0H8) EDETATE SODIUM (UNII: MP1J8420LU) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81858-021-02 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/07/2021 2 NDC:81858-021-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/07/2021 3 NDC:81858-021-06 177 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/07/2021 4 NDC:81858-021-08 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/07/2021 5 NDC:81858-021-12 354 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/07/2021 6 NDC:81858-021-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/07/2021 7 NDC:81858-021-32 946 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/07/2021 8 NDC:81858-021-64 1892 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/07/2021 9 NDC:81858-021-01 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/07/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 05/07/2021 Labeler - Hands First, LLC. (117961848) Registrant - Hands First, LLC. (117961848) Establishment Name Address ID/FEI Business Operations Hands First, LLC. 117961848 MANUFACTURE(81858-021, 81858-021)