Label: ANTIBACTERIAL COCONUT WATER ALOE AND VITAMIN E- benzalkonium chloride liquid
- NDC Code(s): 50157-516-10, 50157-516-23, 50157-516-37, 50157-516-44
- Packager: Brands International Corporation
- 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 January 27, 2021
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- STOP USE
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
ANTIBACTERIAL COCONUT WATER ALOE AND VITAMIN E
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50157-516 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) WATER (UNII: 059QF0KO0R) CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) GLYCOL STEARATE (UNII: 0324G66D0E) LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV) PEG-7 GLYCERYL COCOATE (UNII: VNX7251543) DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50157-516-37 3780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/26/2021 2 NDC:50157-516-10 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/26/2021 3 NDC:50157-516-23 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/26/2021 4 NDC:50157-516-44 443 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/26/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/26/2021 Labeler - Brands International Corporation (243748238) Registrant - Brands International Corporation (243748238) Establishment Name Address ID/FEI Business Operations Brands International Corporation 243748238 manufacture(50157-516)
