Label: BODY PRESCRIPTIONS FRENCH COTTON INFUSED WITH VITAMIN E ANTIBACTERIAL HAND- benzalkonium chloride lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 50563-333-01 - 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 12, 2020
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INGREDIENTS AND APPEARANCE
BODY PRESCRIPTIONS FRENCH COTTON INFUSED WITH VITAMIN E ANTIBACTERIAL HAND
benzalkonium chloride lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50563-333 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 MINERAL OIL (UNII: T5L8T28FGP) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) PEG-100 STEARATE (UNII: YD01N1999R) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) LAURETH-7 (UNII: Z95S6G8201) PHENOXYETHANOL (UNII: HIE492ZZ3T) BENZYL ALCOHOL (UNII: LKG8494WBH) BENZOIC ACID (UNII: 8SKN0B0MIM) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50563-333-01 236.6 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/11/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/11/2020 Labeler - ENCHANTE ACCESSORIES INC. (186050696) Establishment Name Address ID/FEI Business Operations Xiamen Afgamarine Biotechnology Co., Ltd. 420485152 manufacture(50563-333)