Label: FOAMING HAND- benzalkonium chloride lotion
- NDC Code(s): 75447-224-96
- Packager: OptiSource International, 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 April 26, 2022
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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
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INGREDIENTS AND APPEARANCE
FOAMING HAND
benzalkonium chloride lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75447-224 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) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE SODIUM (UNII: MP1J8420LU) SODIUM BENZOATE (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75447-224-96 222 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 04/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/01/2020 Labeler - OptiSource International, Inc (849200159) Registrant - Vi-Jon (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon 790752542 manufacture(75447-224) Establishment Name Address ID/FEI Business Operations Vi-Jon 088520668 manufacture(75447-224)