ANTISEPATION ANTIMICROBIAL CLEANSING GEL- benzethonium chloride gel 
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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Antisepation Antimicrobial Cleansing Gel

DRUG FACTS

Active Ingredient

Benzethonium Chloride (0.20%)

Purpose

Antimicrobial

Inactive Ingredients

Purified Water, Ammonium Lauryl Sulfate, Lauramidopropyl Betaine, Hydroxypropyl Bis-Hydroxyethyldimonium Chloride, Propylene Glycol,
Hydroxypropylmethylcellulose, Sodium Chloride, Diazolidinyl Urea, PEG-4 Laurate, Methylparaben, Propylparaben, 3-iodo-2-propynylbutylcarbamate.

Uses

Antisepation® is a unique, non-drying cleanser. •Designed for all skin types and pH balanced. •Excellent for postoperative care. •May be used as a topical 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.

Directions

•Wet hands and other areas to be treated. •Place a small amount of gel in your hands and work into lather. •Apply lather to areas to be treated using a gentle, circular motion. •Rinse clean.

Other Information

• Alcohol Free
• Moisturizes
• Made In USA

Questions or Comments

A-Cute Derm Inc.
1810 Cravens Road
Stafford, Texas 77477-3534
Phone: 800.922.2883
Internet: www.a-cutederm.com
Email: info@a-cutederm.com
Hours: M-F 8:30pm-5:30pm

Images of Antisepation Labels for 4.0 FL.OZ. and 32 FL. OZ.

AntisepationGel4ozLabel.jpgBottle Label AntisepationGel32ozLabel.jpgRefill Label

ANTISEPATION  ANTIMICROBIAL CLEANSING GEL
benzethonium chloride gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61619-717
Route of Administration CUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 2 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)  
HYDROXYPROPYL BIS-HYDROXYETHYLDIMONIUM CHLORIDE (UNII: 1EO3O1X7HG)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61619-717-14 118.294 mL in 1 BOTTLE, PLASTIC
2 NDC:61619-717-18 236.588 mL in 1 BOTTLE, PLASTIC
3 NDC:61619-717-12 946.353 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 03/13/2014
Labeler - A-Cute Derm, Incorporated (809845803)
Establishment
Name Address ID/FEI Business Operations
Bio-Medical & Pharmaceutical Manufacturing Corporation 072186356 manufacture(61619-717)

Revised: 3/2014
Document Id: 63e89be2-c7f2-43bb-bfc6-58636e9cc0a8
Set id: 0ef1322d-57e8-44be-a74d-a28dd9811c4e
Version: 1
Effective Time: 20140324
 
A-Cute Derm, Incorporated