CLEANSE- benzalkonium chloride 0.13% solution 
Medline Industries, LP

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.

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177 Antibacterial Hand Soap

Active ingredient

Benzalkonium chloride 0.13%

Purpose

Antibacterial

Use

for handwashing to decrease bacteria on the skin

Warnings

For external use only: hands only

When using this product

  • avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

  • irritation or redness develops
  • condition persists for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

benzophenone-4, citric acid, cocamidopropyl betaine, disteareth-75 IPDI, fragrance, glycerin, lauramidopropylamine oxide, lauramine oxide, myristamidopropylamine oxide, PEG-150 distearate, red 40, red 33, sodium benzoate, sodium chloride, tetrasodium EDTA, water, yellow 5

Manufacturing Information

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093, USA

Made in USA with domestic and foreign materials

www.medline.com

1-800-MEDLINE (633-5463)

REF: HHABSP1200G

V2 RB23VJO

Package Label

Front Label V2 RB23VJO

Back Label V2 RB23VJO

CLEANSE 
benzalkonium chloride 0.13% solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-177
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BENZOATE (UNII: OJ245FE5EU)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
SULISOBENZONE (UNII: 1W6L629B4K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
EDETATE SODIUM (UNII: MP1J8420LU)  
GLYCERIN (UNII: PDC6A3C0OX)  
DISTEARETH-75 ISOPHORONE DIISOCYANATE (UNII: 5365FJ30SC)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
WATER (UNII: 059QF0KO0R)  
MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-177-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/19/2016
2NDC:53329-177-08221 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/19/2016
3NDC:53329-177-841000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/19/2016
4NDC:53329-177-253790 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/19/2016
5NDC:53329-177-06473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/19/2016
6NDC:53329-177-741200 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/19/2016
Labeler - Medline Industries, LP (025460908)
Registrant - Medline Industries, LP (025460908)

Revised: 8/2023
Document Id: 027e814e-059e-6fbe-e063-6294a90a1e02
Set id: 3c56b4c2-42f5-66d7-e054-00144ff8d46c
Version: 10
Effective Time: 20230809
 
Medline Industries, LP