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Cleanse by Medline Industries, Inc.

Dosage form: solution
Ingredients: BENZALKONIUM CHLORIDE 0.1g in 100mL
Labeler: Medline Industries, Inc.
NDC Code: 53329-184

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.

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

water, glycerin, lauramine oxide, cocamidopropyl betaine, Aloe barbadensis leaf juice, PEG-150 distearate, cocamide MEA, fragrance, citric acid, tetrasodium EDTA, DMDM hydantoin, benzophenone-4, yellow 5, red 4

CLEANSE 
benzalkonium chloride 0.10% solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-184
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
LAURAMINE OXIDE 
PEG-150 DISTEARATE 
EDETATE SODIUM 
GLYCERIN 
COCO MONOETHANOLAMIDE 
ANHYDROUS CITRIC ACID 
FD&C YELLOW NO. 5 
COCAMIDOPROPYL BETAINE 
ALOE VERA LEAF 
DMDM HYDANTOIN 
FD&C RED NO. 4 
SULISOBENZONE 
Packaging
#Item CodePackage Description
1NDC:53329-184-841000 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/26/2016
Labeler - Medline Industries, Inc. (025460908)

Revised: 11/2016
 
Medline Industries, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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