Label: BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES WINTER BERRY PEPPERMINT VANILLA MINT- benzalkonium chloride kit
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Contains inactivated NDC Code(s)
NDC Code(s): 50563-355-01, 50563-356-01, 50563-357-01, 50563-358-01 - Packager: ENCHANTE ACCESSORIES 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 October 20, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- BODY PRESCRIPTIONS Antibacterial HAND WIPES WINTER BERRY
- Use
- WARNINGS
- Directions
- Inactive ingredients
- BODY PRESCRIPTIONS Antibacterial HAND WIPES PEPPERMINT
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- Warnings
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive Ingredients
- BODY PRESCRIPTIONS Antibacterial HAND WIPES VANILLA MINT
- Active Ingredient
- Purpose
- Uses
- Warnings
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES WINTER BERRY PEPPERMINT VANILLA MINT
benzalkonium chloride kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50563-358 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50563-358-01 1 in 1 KIT 10/20/2020 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 PACKET 20 Part 2 1 PACKET 20 Part 3 1 PACKET 20 Part 1 of 3 BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES WINTER BERRY
benzalkonium chloride solutionProduct Information Item Code (Source) NDC:50563-355 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 4.5 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50563-355-01 20 in 1 PACKET; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/20/2020 Part 2 of 3 BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES PEPPERMINT
benzalkonium chloride solutionProduct Information Item Code (Source) NDC:50563-356 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 4.5 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50563-356-01 20 in 1 PACKET; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/20/2020 Part 3 of 3 BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES VANILLA MINT
benzalkonium chloride solutionProduct Information Item Code (Source) NDC:50563-357 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 4.5 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50563-357-01 20 in 1 PACKET; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/20/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/20/2020 Labeler - ENCHANTE ACCESSORIES INC. (186050696) Establishment Name Address ID/FEI Business Operations Zhejiang Ruolin Hygienic Products Co., Ltd. 415426870 manufacture(50563-358)