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Antisepation

Dosage form: lotion
Ingredients: BENZETHONIUM CHLORIDE 2mg in 1mL
Labeler: A-Cute Derm, Incorporated
NDC Code: 61619-717

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.

DRUG FACTS

Kills 99.9% of harmful germs in 30 seconds.

Active Ingredients

Benzethonium Chloride (0.2%)

Purpose

Antimicrobial

Uses

•AntisepationTM 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.

Inactive ingredients

Purified Water, Ammonium Lauryl Sulfate,

Lauramidopropyl Betaine, Hydroxypropyl

Bis-Hydroxyethyl-dimonium Chloride,

Propylene Glycol, Hydroxypropylmethylcellulose,

Sodium Chloride, Diazolidinyl

Urea, PEG-4 Laurate, Methylparaben,

Propylparaben, 3-iodo-2-propynylbutylcarbamate.

Other Information

•Alcohol Free •Moisturizes •Made in USA

Questions or Comments

A-Cute Derm, Inc.

1810 Cravens Road

Stafford, TX 77477

800.922.2883

M-F 8:30am-5:30pm

info@a-cutederm.com

www.a-cutederm.com

Principal Display Panel

ANTISEPATIONTM

CLEANSING GEL

Kills 99.9% of Harmful

Germs In 30 Seconds

NDC# 61619-717-14

4.0 FL OZ (118.3 ml

ANTISEPATION 
benzethonium chloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem 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
AMMONIUM LAURYL SULFATE 
HYDROXYPROPYL BIS-HYDROXYETHYLDIMONIUM CHLORIDE 
HYPROMELLOSES 
SODIUM CHLORIDE 
DIAZOLIDINYL UREA 
PEG-4 LAURATE 
METHYLPARABEN 
IODOPROPYNYL BUTYLCARBAMATE 
LAURAMIDOPROPYL BETAINE 
PROPYLPARABEN 
PROPYLENE GLYCOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:61619-717-14118.294 mL in 1 BOTTLE, PLASTIC
2NDC:61619-717-12946.4 mL in 1 BOTTLE, PLASTIC
3NDC:61619-717-0729.6 mL in 1 BOTTLE, PLASTIC
4NDC:61619-717-283800 mL in 1 BOTTLE, PLASTIC
5NDC:61619-717-18236.6 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E02/05/2016
Labeler - A-Cute Derm, Incorporated (809845803)
Establishment
NameAddressID/FEIOperations
Bio-Medical & Pharmaceutical Manufacturing Corporation072186356manufacture(61619-717)

 
A-Cute Derm, Incorporated

Medically reviewed on Apr 11, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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