Label: BENZALKONIUM CHLORIDE- benzalkonium chloride 0.13% soap
- NDC Code(s): 11822-0280-3, 11822-0280-4, 11822-0280-5
- Packager: Rite Aid
- 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 October 28, 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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SPL UNCLASSIFIED SECTION
This product is not manufactured or distributed by
Colgate-Palmolive Company, distributor of Softsoap
Antibacterial Liquid HandSoap Crisp Clean.
peace of mind guarantee
If you are not satisfied,
we'll happily refund your money.
DISTRIBUTED BY: RITE AID
30 HUNTER LANE
CAMP HILL, PA 17011
www.riteaid.com
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INGREDIENTS AND APPEARANCE
BENZALKONIUM CHLORIDE
benzalkonium chloride 0.13% soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0280 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 ACETATE (UNII: DSO12WL7AU) EDETATE SODIUM (UNII: MP1J8420LU) SULISOBENZONE (UNII: 1W6L629B4K) SODIUM BENZOATE (UNII: OJ245FE5EU) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-0280-3 221 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/19/2021 2 NDC:11822-0280-4 1470 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/19/2021 3 NDC:11822-0280-5 332 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/19/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/19/2021 Labeler - Rite Aid (014578892) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(11822-0280) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(11822-0280)