Drug Labeling and Warnings

Drug Details

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CLEANSE- benzalkonium chloride 0.13% solution 
Medline Industries, Inc.

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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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

  • wet hands
  • apply palmful to hands
  • scrub thoroughly
  • rinse thoroughly

Inactive ingredients

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

Questions?

Call 1-800-MEDLINE

www.medline.com
©2018 Medline Industries, Inc., Made in USA of foreign and

domestic materials for Medline Industries, Inc., Three Lakes Drive,

Northfield, IL 60093 USA. 1-800-MEDLINE RK18VJO

Label Gallon

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
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
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)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
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: 53329-177-06273 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/19/2016
4NDC: 53329-177-841000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/19/2016
5NDC: 53329-177-253790 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/19/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/19/2016
Labeler - Medline Industries, Inc. (025460908)

Revised: 11/2019
 
Medline Industries, Inc.


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