SPL v8
SPL
SPL Set ID 0ef1322d-57e8-44be-a74d-a28dd9811c4e
Route
CUTANEOUS
Published
Effective Date 2021-12-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzethonium (2 mg)
Inactive Ingredients
Ammonium Lauryl Sulfate Hydroxypropyl Bis-hydroxyethyldimonium Chloride Hypromelloses Sodium Chloride Diazolidinyl Urea Peg-4 Laurate Methylparaben Iodopropynyl Butylcarbamate Lauramidopropyl Betaine Propylparaben Propylene Glycol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-02-05

Description

Antimicrobial

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

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.

Drug Facts

Antimicrobial

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

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.

Questions Or Comments

A-Cute Derm, Inc.

1810 Cravens Road

Stafford, TX 77477

800.922.2883

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

[email protected]

www.a-cutederm.com

Principal Display Panel

Antisepation cleansing gel


Structured Label Content

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.

Purpose

Antimicrobial

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.

Drug Facts (DRUG FACTS)

Antimicrobial

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

Active Ingredients

Benzethonium Chloride (0.2%)

Inactive Ingredients (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 (Questions or Comments)

A-Cute Derm, Inc.

1810 Cravens Road

Stafford, TX 77477

800.922.2883

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

[email protected]

www.a-cutederm.com

Principal Display Panel

Antisepation cleansing gel


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)