ANTIMICROBIAL CLEANSING GEL- benzethonium chloride lotion

Antimicrobial cleansing gel by

Drug Labeling and Warnings

Antimicrobial cleansing gel by is a Otc medication manufactured, distributed, or labeled by A-Cute Derm, Incorporated, Bio-Medical & Pharmaceutical Manufacturing Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Kills 99.9% of harmful germs in 30 seconds.

Active Ingredients

Benzethonium Chloride (0.2%)

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.

Purpose

Antimicrobial Wash

Uses

B-KLEER™ is a unique, non-drying cleanser. Use on all skin types. pH balanced. 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, TX 77477

800.922.2883

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

info@a-cutederm.com

www.a-cutederm.com

Principal Display Panel

INGREDIENTS AND APPEARANCE

ANTIMICROBIAL CLEANSING GEL 
benzethonium chloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61619-104
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: 61619-104-04	118.29 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/20/2020
2	NDC: 61619-104-32	946.35 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/20/2020
3	NDC: 61619-104-01	29.57 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/20/2020
4	NDC: 61619-104-08	236.59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	02/20/2020

Labeler - A-Cute Derm, Incorporated (809845803)

Establishment
Name	Address	ID/FEI	Business Operations
Bio-Medical & Pharmaceutical Manufacturing Corporation		072186356	manufacture(61619-104)