Your browser does not support JavaScript! ANTISEPATION ANTIMICROBIAL CLEANSING GEL (BENZETHONIUM CHLORIDE) GEL [A-CUTE DERM, INCORPORATED]
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RxNorm Names

ANTISEPATION ANTIMICROBIAL CLEANSING GEL (benzethonium chloride) gel
[A-Cute Derm, Incorporated]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

DRUG FACTS

  • Kills 99.9% of harmful germs in 30 seconds

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.

  • ​Keep out of reach of children

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:61619-717
Route of AdministrationCUTANEOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (BENZETHONIUM) BENZETHONIUM CHLORIDE2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
AMMONIUM LAURYL SULFATE 
LAURAMIDOPROPYL BETAINE 
HYDROXYPROPYL BIS-HYDROXYETHYLDIMONIUM CHLORIDE 
PROPYLENE GLYCOL 
HYPROMELLOSES 
SODIUM CHLORIDE 
DIAZOLIDINYL UREA 
PEG-4 LAURATE 
METHYLPARABEN 
PROPYLPARABEN 
IODOPROPYNYL BUTYLCARBAMATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61619-717-14118.294 mL in 1 BOTTLE, PLASTIC
2NDC:61619-717-18236.588 mL in 1 BOTTLE, PLASTIC
3NDC:61619-717-12946.353 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/13/2014
Labeler - A-Cute Derm, Incorporated (809845803)
Establishment
NameAddressID/FEIBusiness Operations
Bio-Medical & Pharmaceutical Manufacturing Corporation072186356manufacture(61619-717)

Revised: 3/2014
 
A-Cute Derm, Incorporated

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