Label: ADVANCED HAND SANITIZER- benzalkonium chloride gel
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Contains inactivated NDC Code(s)
NDC Code(s): 90117-201-01, 90117-201-02, 90117-201-03, 90117-201-04, view more90117-201-05, 90117-201-06, 90117-201-07 - Packager: Safe Palms, 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 August 25, 2020
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- Active Ingredients
- Purpose
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- Warnings
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- Other Information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ADVANCED HAND SANITIZER
benzalkonium chloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:90117-201 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:90117-201-01 60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/25/2020 2 NDC:90117-201-02 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/25/2020 3 NDC:90117-201-03 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/25/2020 4 NDC:90117-201-04 480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/25/2020 5 NDC:90117-201-05 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/25/2020 6 NDC:90117-201-06 1892 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/25/2020 7 NDC:90117-201-07 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/25/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/25/2020 Labeler - Safe Palms, LLC (117609055) Establishment Name Address ID/FEI Business Operations Music City Laboratories, Llc 117409349 MANUFACTURE(90117-201)