Drug Facts 62654-232

Drug Facts 62654-232
SPL v2
SPL
SPL Set ID 4cf4aa1d-4a2e-4ab1-9f16-af1a8c136660
Route
TOPICAL
Published
Effective Date 2018-04-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzethonium (0.13 g)
Inactive Ingredients
Water Lauramine Oxide Lauramidopropylamine Oxide Peg-150 Distearate Coco Monoethanolamide Glycerin Cetrimonium Chloride Dmdm Hydantoin Iodopropynyl Butylcarbamate Citric Acid Monohydrate Fd&c Yellow No. 5 Fd&c Red No. 4 Sodium Hydroxide Sodium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-04-09
Description

Active ingredient: Benzethonium Chloride 0.13%

Medication Information

Warnings and Precautions

Warnings

For External Use Only.

Indications and Usage

Uses

For handwashing to decrease bacteria on the skin.

Dosage and Administration

Directions

Apply to hands and wet as needed.

Lather vigorously for at least 15 seconds.

Wash skin, rinse thoroughly and dry.

Description

Active ingredient: Benzethonium Chloride 0.13%

Section 44425-7

Other information

Protect from freezing.Avoid excessive heat.

Store at 40-95 F (4-35 C)

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50570-1

Do not use in the eyes.

Discontinue use if irritation and redness develops.

If condition persists for more than 72 hours consult a doctor.

Section 51727-6

Inactive Ingredients

Purified Water, Lauramine Oxide,Lauramidopropylamine Oxide, PEG-150 Distearate, Cocamide MEA, Glycerin, Cetrimonium Chloride, Fragrance, DMDM Hydantoin, Iodopropynyl Carbamate, Citric Acid, Yellow 5, Red 4, (may contain Sodium Hydroxide, Sodium Chloride).

Section 51945-4

DermaCen

Antimicrobial-B

Hand Soap

An antimicrobial

hand soap for healthcare

professionals to decrease

bacteria on the skin

Net Contents:

9 oz (266mL)

Section 53413-1

Questions?

Call 800-255-0262

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active ingredient:

Benzethonium Chloride 0.13%

Structured Label Content

Indications and Usage (34067-9)

Uses

For handwashing to decrease bacteria on the skin.

Dosage and Administration (34068-7)

Directions

Apply to hands and wet as needed.

Lather vigorously for at least 15 seconds.

Wash skin, rinse thoroughly and dry.

Warnings and Precautions (34071-1)

Warnings

For External Use Only.

Section 44425-7 (44425-7)

Other information

Protect from freezing.Avoid excessive heat.

Store at 40-95 F (4-35 C)

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50570-1 (50570-1)

Do not use in the eyes.

Discontinue use if irritation and redness develops.

If condition persists for more than 72 hours consult a doctor.

Section 51727-6 (51727-6)

Inactive Ingredients

Purified Water, Lauramine Oxide,Lauramidopropylamine Oxide, PEG-150 Distearate, Cocamide MEA, Glycerin, Cetrimonium Chloride, Fragrance, DMDM Hydantoin, Iodopropynyl Carbamate, Citric Acid, Yellow 5, Red 4, (may contain Sodium Hydroxide, Sodium Chloride).

Section 51945-4 (51945-4)

DermaCen

Antimicrobial-B

Hand Soap

An antimicrobial

hand soap for healthcare

professionals to decrease

bacteria on the skin

Net Contents:

9 oz (266mL)

Section 53413-1 (53413-1)

Questions?

Call 800-255-0262

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active ingredient:

Benzethonium Chloride 0.13%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:40.767757 · Updated: 2026-03-14T23:05:34.774689