Label: HAND SANITIZER- benzalkonium chloride spray
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Contains inactivated NDC Code(s)
NDC Code(s): 77238-241-11, 77238-241-21, 77238-241-41 - Packager: DGH Pharma, 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 July 29, 2022
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- Active Ingredient(s)
- Purpose
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- Warnings
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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- Inactive ingredients
- Package Label - Principal Display Panel
- Additional Label
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
benzalkonium chloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77238-241 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.1 g in 100 mL Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) 2.2 g in 100 mL POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 0.21 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 0.21 g in 100 mL POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.2 g in 100 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.4 g in 100 mL MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) 0.005 g in 100 mL CUPRIC CHLORIDE (UNII: S2QG84156O) 0.267 g in 100 mL LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.1 g in 100 mL ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA) 0.15 g in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77238-241-11 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2020 2 NDC:77238-241-21 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/05/2020 3 NDC:77238-241-41 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/01/2020 Labeler - DGH Pharma, Inc. (128884560) Registrant - DGH Pharma, Inc. (128884560) Establishment Name Address ID/FEI Business Operations DGH Pharma, Inc. 128884560 manufacture(77238-241)
