Label: HAND WASH- benzalkonium chloride soap
- NDC Code(s): 55315-403-49, 55315-403-64, 55315-403-68, 55315-403-96
- Packager: Fred's Inc
- 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 June 12, 2023
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- Active ingredients
- 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 section
- principal display panel
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INGREDIENTS AND APPEARANCE
HAND WASH
benzalkonium chloride soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55315-403 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) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV) SODIUM CHLORIDE (UNII: 451W47IQ8X) MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T) glycerin (UNII: PDC6A3C0OX) DISTEARETH-75 ISOPHORONE DIISOCYANATE (UNII: 5365FJ30SC) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE SODIUM (UNII: MP1J8420LU) SULISOBENZONE (UNII: 1W6L629B4K) SODIUM BENZOATE (UNII: OJ245FE5EU) FD&C RED NO. 4 (UNII: X3W0AM1JLX) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55315-403-96 221 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/23/2015 2 NDC:55315-403-49 443 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/23/2015 3 NDC:55315-403-64 1893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/23/2015 4 NDC:55315-403-68 1656 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/23/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/23/2015 Labeler - Fred's Inc (005866116) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(55315-403) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(55315-403)