Label: BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES BERRY TWIST- benzalkonium chloride solution
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Contains inactivated NDC Code(s)
NDC Code(s): 50563-245-01 - 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 August 19, 2020
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- Active Ingredient
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- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES BERRY TWIST
benzalkonium chloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50563-245 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 GLYCERIN (UNII: PDC6A3C0OX) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) FRAGARIA CHILOENSIS WHOLE (UNII: R3Q9SDF6YH) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) RUBUS IDAEUS WHOLE (UNII: 7GOM628K2Z) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50563-245-01 3 in 1 PACKAGE 08/19/2020 1 20 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/19/2020 Labeler - ENCHANTE ACCESSORIES INC. (186050696) Establishment Name Address ID/FEI Business Operations Zhejiang Ruolin Hygienic Products Co., Ltd. 415426870 manufacture(50563-245)