SPL v5
SPL
SPL Set ID 9eefba02-85ae-c966-e053-2995a90a27a3
Route
CUTANEOUS
Published
Effective Date 2020-02-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-02-20

Description

Antimicrobial

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

Antimicrobial

Uses

B-KLEER™ 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

antimicrobial


Structured Label Content

Uses

B-KLEER™ 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

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

antimicrobial


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)