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

Antimicrobial

Active Ingredients

Benzethonium Chloride (0.2%)

Purpose

Antimicrobial

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

For external use only.
Do not use in eyes.
Ask a doctor before use if you have deep wounds or puncture wounds.
Stop use and ask a doctor if irritation develops.

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

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.

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

Antisepation cleansing gel

antisepation cleansing gel

ANTISEPATION 
benzethonium chloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61619-717
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61619-717-14118.294 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/05/2016
2NDC:61619-717-12946.4 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/05/2016
3NDC:61619-717-101 in 1 BOX12/22/2021
3NDC:61619-717-0729.6 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:61619-717-283800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/05/2016
5NDC:61619-717-18236.6 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/05/2016
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/FEIBusiness Operations
Bio-Medical & Pharmaceutical Manufacturing Corporation072186356manufacture(61619-717)

Revised: 12/2021
Document Id: d3d2f9a2-7dfb-745a-e053-2a95a90a6a3d
Set id: 0ef1322d-57e8-44be-a74d-a28dd9811c4e
Version: 8
Effective Time: 20211223
 
A-Cute Derm, Incorporated