Label: HAND WASH- benzalkonium chloride liquid
- NDC Code(s): 41250-483-45, 41250-483-96
- Packager: Meijer Distribution, 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 February 17, 2023
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- Active ingredient
- Purpose
- Use
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions
- Inactive ingredients
- Adverse reaction
- principal display panel
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INGREDIENTS AND APPEARANCE
HAND WASH
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-483 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 WATER (UNII: 059QF0KO0R) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T) GLYCERIN (UNII: PDC6A3C0OX) LINALOOL, (+)- (UNII: F4VNO44C09) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) LIMONENE, (+)- (UNII: GFD7C86Q1W) GERANIOL (UNII: L837108USY) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE SODIUM (UNII: MP1J8420LU) SULISOBENZONE (UNII: 1W6L629B4K) SODIUM BENZOATE (UNII: OJ245FE5EU) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41250-483-96 221 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/20/2019 2 NDC:41250-483-45 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/20/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 12/20/2019 Labeler - Meijer Distribution, Inc (006959555) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(41250-483) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(41250-483)