Label: HOME FORMATION ANTIBACTERIA -BERRY- benzalkonium chloride liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 68121-007-01 - Packager: PATCOS COSMETICS (INDIA) PRIVATE LIMITED
- Category: HUMAN OTC DRUG LABEL
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 February 10, 2021
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Warnings
- Uses
- Directions
- KEEP OUT OF REACH OF CHILDREN
-
Inactive ingredient
Water, Sodium Laureth Sulphate, Sodium Laureth sulfate & Glycol Distearate & Cocamide MEA & Laureth - 10, Cocamido Propyl Betaine,
Cocomonoethanolamide, Sodium Chloride, Glycerine, Perfume, PEG 150 Distearate, Bronopol, Disodium EDTA, Phenoxyethanol, Benzophenone 3, Citric Acid, FD & C Red 40, CI. No 16035. - SPL UNCLASSIFIED SECTION
- Label
-
INGREDIENTS AND APPEARANCE
HOME FORMATION ANTIBACTERIA -BERRY
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68121-007 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 SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCERIN (UNII: PDC6A3C0OX) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) COCO MONOETHANOLAMIDE (UNII: C80684146D) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) BRONOPOL (UNII: 6PU1E16C9W) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) PHENOXYETHANOL (UNII: HIE492ZZ3T) BENZOPHENONE (UNII: 701M4TTV9O) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C RED NO. 40 (UNII: WZB9127XOA) WATER (UNII: 059QF0KO0R) GLYCOL DISTEARATE (UNII: 13W7MDN21W) LAURETH-10 (UNII: BD7AST04GA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68121-007-01 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/29/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/29/2021 Labeler - PATCOS COSMETICS (INDIA) PRIVATE LIMITED (916169451) Establishment Name Address ID/FEI Business Operations PATCOS COSMETICS (INDIA) PRIVATE LIMITED 675973979 manufacture(68121-007)