Label: HAND WASH- benzalkonium chloride soap
- NDC Code(s): 71897-022-08, 71897-022-45, 71897-022-86
- Packager: Veritiv Operating Company
- 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 September 19, 2022
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- Official Label (Printer Friendly)
- 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
- SPL UNCLASSIFIED SECTION
- principal panel display
-
INGREDIENTS AND APPEARANCE
HAND WASH
benzalkonium chloride soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71897-022 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) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) SODIUM CHLORIDE (UNII: 451W47IQ8X) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) glycerin (UNII: PDC6A3C0OX) DISTEARETH-75 ISOPHORONE DIISOCYANATE (UNII: 5365FJ30SC) 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:71897-022-08 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/23/2018 2 NDC:71897-022-86 3790 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/23/2018 3 NDC:71897-022-45 1150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/23/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/23/2018 Labeler - Veritiv Operating Company (006989982) Registrant - Vi-Jon, LLC (088520668) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(71897-022) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(71897-022)