Label: DISNEY MICKEY MOUCE BERRY SCENTED HAND SANITIZER 01- benzalkonium chloride gel
DISNEY PRINCESS BUBBLE GUM SCENTED HAND SANITIZER 01- benzalkonium chloride gel
DISNEY PRINCESS WATERMELON SCENTED HAND SANITIZER 01- benzalkonium chloride gel
DISNEY PRINCESS GRAPE SCENTED HAND SANITIZER 01- benzalkonium chloride gel
DISNEY PRINCESS BLUEBERRY SCENTED HAND SANITIZER 01- benzalkonium chloride gel
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Contains inactivated NDC Code(s)
NDC Code(s): 54860-097-01, 54860-098-01, 54860-099-01, 54860-200-01, view more54860-201-01 - 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 27, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug facts
- Active ingredient purpose
- Use
- Warnings
- Direction
- Inactive ingredients
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DISNEY MICKEY MOUCE BERRY SCENTED HAND SANITIZER 01
benzalkonium chloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54860-097 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 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 WATER O-18 (UNII: 7QV8F8BYNJ) 96 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 1.5 mL in 100 mL CARBOMER 934 (UNII: Z135WT9208) 0.24 mL in 100 mL SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.12 mL in 100 mL HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) 0.15 mL in 100 mL FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.1 mL in 100 mL FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 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 D&C RED NO. 33 (UNII: 9DBA0SBB0L) 0.1 mL in 100 mL Product Characteristics Color blue Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54860-097-01 59 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package 11/27/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/27/2018 DISNEY PRINCESS BUBBLE GUM SCENTED HAND SANITIZER 01
benzalkonium chloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54860-098 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 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 HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) 0.15 mL in 100 mL WATER O-18 (UNII: 7QV8F8BYNJ) 96 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 MYRISTICA FRAGRANS FRUIT (UNII: GOO22BTU71) 0.3 mL in 100 mL D&C RED NO. 33 (UNII: 9DBA0SBB0L) 0.1 mL in 100 mL FD&C RED NO. 40 (UNII: WZB9127XOA) 0.1 mL in 100 mL Product Characteristics Color red Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54860-098-01 59 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package 11/27/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/27/2018 DISNEY PRINCESS WATERMELON SCENTED HAND SANITIZER 01
benzalkonium chloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54860-099 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 green Score Shape Size Flavor WATERMELON Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54860-099-01 59 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package 11/27/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/27/2018 DISNEY PRINCESS GRAPE SCENTED HAND SANITIZER 01
benzalkonium chloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54860-200 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 purple Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54860-200-01 59 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package 11/27/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/27/2018 DISNEY PRINCESS BLUEBERRY SCENTED HAND SANITIZER 01
benzalkonium chloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54860-201 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.1 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER O-18 (UNII: 7QV8F8BYNJ) 96 mL in 100 mL COCETH-7 (UNII: 58Y261JLH5) 0.68 mL in 100 mL POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) 0.15 mL in 100 mL SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.12 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 1.5 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 MYRISTICA FRAGRANS FRUIT (UNII: GOO22BTU71) 0.3 mL in 100 mL FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.1 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 YELLOW NO. 5 (UNII: I753WB2F1M) 0.1 mL in 100 mL Product Characteristics Color blue Score Shape Size Flavor BLUEBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54860-201-01 59 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package 11/27/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/27/2018 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(54860-097, 54860-098, 54860-099, 54860-200, 54860-201)
