Label: GUARD ALCOHOL-FREE HAND SANITIZER- benzalkonium chloride gel
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Contains inactivated NDC Code(s)
NDC Code(s): 63148-514-02, 63148-514-08, 63148-514-32 - Packager: Apollo Health and Beauty Care 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 April 20, 2020
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INGREDIENTS AND APPEARANCE
GUARD ALCOHOL-FREE HAND SANITIZER
benzalkonium chloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63148-514 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) HYDROXYETHYL CELLULOSE (5000 CPS AT 1%) (UNII: X70SE62ZAR) EDETATE SODIUM (UNII: MP1J8420LU) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM HYDROXIDE (UNII: 55X04QC32I) DMDM HYDANTOIN (UNII: BYR0546TOW) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63148-514-02 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/17/2020 2 NDC:63148-514-08 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/17/2020 3 NDC:63148-514-32 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/17/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 04/17/2020 Labeler - Apollo Health and Beauty Care Inc. (201901209) Registrant - Apollo Health and Beauty Care Inc. (201901209) Establishment Name Address ID/FEI Business Operations Apollo Health and Beauty Care Inc. 201901209 manufacture(63148-514)