ANTISEPATION- benzethonium chloride lotion 
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

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 Antiseption 4 fl. oz.

ANTISEPATION 
benzethonium chloride lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61619-717
Route of Administration CUTANEOUS
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
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
HYDROXYPROPYL BIS-HYDROXYETHYLDIMONIUM CHLORIDE (UNII: 1EO3O1X7HG)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61619-717-14 118.294 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/05/2016
2 NDC:61619-717-12 946.4 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/05/2016
3 NDC:61619-717-07 29.6 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/05/2016
4 NDC:61619-717-28 3800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/05/2016
5 NDC:61619-717-18 236.6 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/05/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 02/05/2016
Labeler - A-Cute Derm, Incorporated (809845803)
Establishment
Name Address ID/FEI Business Operations
Bio-Medical & Pharmaceutical Manufacturing Corporation 072186356 manufacture(61619-717)

Revised: 4/2016
Document Id: 3036c141-e236-6519-e054-00144ff88e88
Set id: 0ef1322d-57e8-44be-a74d-a28dd9811c4e
Version: 4
Effective Time: 20160411
 
A-Cute Derm, Incorporated