ANTIMICROBIAL FOAMING SANITIZER- benzethonium chloride liquid liquid 
A-Cute Derm, Incorporated

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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DRUG FACTS

Foaming Antimicrobial Sanitizer

Active Ingredient

Benzethonium Chloride 0.2%

Antimicrobial

Inactive Ingredients

Water,Lauramidopropyl Betaine, Propylene Glycol, Diazolidinyl Urea, Methylparaben,Propylparaben.

Purpose

First Aid Antimicrobial Sanitizer

Use

Kleer-Plex is a unique, non-drying sanitizer. Designed for all skin types and pH balanced. Kills 99.9% of germs including Staph,

Pseudomonas, and E. coli. Excellent for post-operative care. May be used as a First Aid Antimicrobial to help protect against

skin infection.

Warnings

External use only. Do not use in eyes. In case of deep wounds or puncture wounds, consult a physician. If irritation develops and persists for more than a few days, discontinue use and consult a physician. .

Keep Out Of Reach Of Children

Other Information

Alcohol Free

Moisturizes

Made In USA

Questions or Comments

Bio-Medical & Pharm., Mfg. Corp.

4311 South Dr., Houston, TX 77053

Phone: 281.835.8051

Internet: www.kleerplex.com

Directions

Dispense foam into palms, then spread onto hands and other areas to be treated.

1.7 oz Antisepation

A-Cute Derm Medical Skincare

Antisepation Foam Sanitizer

NDC #: 61619-718-37

1.7 FL OZ(50.0 ml)

ANTIMICROBIAL FOAMING SANITIZER 
benzethonium chloride liquid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61619-718
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)  
2-HEXENAL PROPYLENE GLYCOL ACETAL, (1E)- (UNII: ZBS49DF5S4)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61619-718-3750 g in 1 BOTTLE; Type 0: Not a Combination Product10/27/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/27/2015
Labeler - A-Cute Derm, Incorporated (809845803)
Establishment
NameAddressID/FEIBusiness Operations
Bio-Medical & Pharmaceutical Manufacturing Corporation072186356manufacture(61619-718)

Revised: 10/2015
Document Id: 228d0fc2-16c8-2b16-e054-00144ff88e88
Set id: 228d0fc2-16c6-2b16-e054-00144ff88e88
Version: 2
Effective Time: 20151020
 
A-Cute Derm, Incorporated