Label: HAND SANITIZER- benzalkonium chloride gel
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Contains inactivated NDC Code(s)
NDC Code(s): 77238-231-11, 77238-231-14, 77238-231-24, 77238-231-31, view more77238-231-41, 77238-231-44, 77238-231-48 - 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
- Use
- Warnings
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive ingredients
- Package Label - Principal Display Panel
- Package Label for second product
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
benzalkonium chloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77238-231 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 CUPRIC CHLORIDE (UNII: S2QG84156O) 0.201 g in 100 mL MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) 0.05 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 1.65 g in 100 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.4 g in 100 mL POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) 1.95 g in 100 mL POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 1.65 g in 100 mL WATER (UNII: 059QF0KO0R) POLYSORBATE 20 (UNII: 7T1F30V5YH) 2 g in 100 mL HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) 0.65 g in 100 mL LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.18 g in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77238-231-14 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2020 2 NDC:77238-231-24 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/06/2020 3 NDC:77238-231-11 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 09/01/2020 4 NDC:77238-231-31 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 06/01/2022 5 NDC:77238-231-41 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 07/01/2022 6 NDC:77238-231-44 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2022 7 NDC:77238-231-48 3785 mL in 1 JUG; 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(77238-231)
