Label: BODY PRESCRIPTIONS FERN INFUSED WITH VITAMIN E ANTIBACTERIAL HAND- benzalkonium chloride lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 50563-429-01 - Packager: ENCHANTE ACCESSORIES INC.
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated March 27, 2021
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INGREDIENTS AND APPEARANCE
BODY PRESCRIPTIONS FERN INFUSED WITH VITAMIN E ANTIBACTERIAL HAND
benzalkonium chloride lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50563-429 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 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) FD&C RED NO. 4 (UNII: X3W0AM1JLX) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) MINERAL OIL (UNII: T5L8T28FGP) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) PEG-100 STEARATE (UNII: YD01N1999R) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50563-429-01 236.6 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/27/2021 Labeler - ENCHANTE ACCESSORIES INC. (186050696) Establishment Name Address ID/FEI Business Operations Xiamen Afgamarine Biotechnology Co., Ltd. 420485152 manufacture(50563-429)