A-CUTE DERM ANTISEPATION- benzethonium chloride gel

A-Cute Derm Antisepation by

Drug Labeling and Warnings

A-Cute Derm Antisepation by is a Otc medication manufactured, distributed, or labeled by ABBE Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

A-Cute Derm Antisepation Cleansing Gel

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

Distributed by ABBE Laboratories, Inc.
1095 Route 110 Farmingdale, NY 11735
1-800-457-0990

Principal Display Panel

A-Cute

Derm®

medical skincare

Antisepation™

Cleansing Gel

8.0 FL OZ (236.6 ml)

INGREDIENTS AND APPEARANCE

A-CUTE DERM ANTISEPATION 
benzethonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68605-7171(NDC:25280-005)
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: 68605-7171-4	118.294 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2022
2	NDC: 68605-7171-2	946.4 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2022
3	NDC: 68605-7171-8	236.6 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M004	05/01/2022

Labeler - ABBE Laboratories, Inc. (781745286)

Establishment
Name	Address	ID/FEI	Business Operations
ABBE Laboratories, Inc.		781745286	repack(68605-7171)