Label: TROLLS GRAPE SCENTED HAND SANITIZER 01- benzalkonium chloride gel
TROLLS STRAWBERRY SCENTED HAND SANITIZER 01- benzalkonium chloride gel
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Contains inactivated NDC Code(s)
NDC Code(s): 54860-124-01, 54860-125-01 - Packager: ShenZhen Lantern Science Co.,Ltd.
- 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 November 13, 2019
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INGREDIENTS AND APPEARANCE
TROLLS GRAPE SCENTED HAND SANITIZER 01
benzalkonium chloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54860-124 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 POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) 0.15 mL in 100 mL COCETH-7 (UNII: 58Y261JLH5) 0.68 mL in 100 mL D&C RED NO. 33 (UNII: 9DBA0SBB0L) 0.1 mL in 100 mL MYRISTICA FRAGRANS FRUIT (UNII: GOO22BTU71) 0.3 mL in 100 mL FD&C RED NO. 40 (UNII: WZB9127XOA) 0.1 mL in 100 mL FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.1 mL in 100 mL FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.1 mL in 100 mL WATER O-18 (UNII: 7QV8F8BYNJ) 96 mL in 100 mL CARBOMER 934 (UNII: Z135WT9208) 0.24 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 0.68 mL in 100 mL PPG-1-PEG-9 LAURYL GLYCOL ETHER (UNII: 5R8J43K25L) 0.68 mL in 100 mL SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.12 mL in 100 mL Product Characteristics Color purple Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54860-124-01 59 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package 11/13/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/13/2019 TROLLS STRAWBERRY SCENTED HAND SANITIZER 01
benzalkonium chloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54860-125 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 WATER O-18 (UNII: 7QV8F8BYNJ) 96 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 1.5 mL in 100 mL COCETH-7 (UNII: 58Y261JLH5) 0.68 mL in 100 mL PPG-1-PEG-9 LAURYL GLYCOL ETHER (UNII: 5R8J43K25L) 0.68 mL in 100 mL CARBOMER 934 (UNII: Z135WT9208) 0.24 mL in 100 mL SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.12 mL in 100 mL POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) 0.15 mL in 100 mL MYRISTICA FRAGRANS FRUIT (UNII: GOO22BTU71) 0.3 mL in 100 mL FD&C RED NO. 40 (UNII: WZB9127XOA) 0.1 mL in 100 mL D&C RED NO. 33 (UNII: 9DBA0SBB0L) 0.1 mL in 100 mL FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.1 mL in 100 mL FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.1 mL in 100 mL Product Characteristics Color red Score Shape Size Flavor STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54860-125-01 59 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package 11/13/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/13/2019 Labeler - ShenZhen Lantern Science Co.,Ltd. (421222423) Registrant - Townley Inc. (016956158) Establishment Name Address ID/FEI Business Operations ShenZhen Lantern Science Co.,Ltd. 421222423 manufacture(54860-124, 54860-125)