SPL v1
SPL
SPL Set ID 9cc31ba8-5323-60e6-e053-2a95a90a1a9d
Route
TOPICAL
Published
Effective Date 2020-03-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzethonium (0.13 g)
Inactive Ingredients
Fd&c Yellow No. 5 Fd&c Red No. 4 Water Cocamidopropyl Betaine Lauramine Oxide Glycerin Cetrimonium Chloride Iodopropynyl Butylcarbamate Sodium Hydroxide Citric Acid Monohydrate Dmdm Hydantoin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-06
Description

Benzethonium Chloride 0.13%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Benzethonium Chloride 0.13%

Uses
  • For handwashing to decrease bacteria on the skin.
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 51945-4

CLEAR

The Choice Is Clear

SOAP SUDS

Antibacterial Soap

purpose:

cleans + moisturizes

scent:

floral

8.5 Fl.Oz. 125mL

A Brand By PHARMAPACKS

Warnings

For external use only.

Directions
  • Apply to hands and wet as needed.
  • Lather vigorously for at least 15 seconds.
  • Wash skin, rinse thoroughly and dry.
Questions?

Call 1-855-797-2257

Active Ingredient

Benzethonium Chloride 0.13%

Other Information

Protect from freezing.

Avoid excessive heat.

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

Inactive Ingredients

Purified Water, Cocamidopropyl Betaine, Laramine Oxide, Glycerin, Cetrimonim Chloride, Fragrance, DMDM Hydantoin, Iodopropynyl Carbamate, Yellow 6, Red 4, (may contain Citric Acid, Sodium Hydroxide)

Structured Label Content

Uses
  • For handwashing to decrease bacteria on the skin.
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 51945-4 (51945-4)

CLEAR

The Choice Is Clear

SOAP SUDS

Antibacterial Soap

purpose:

cleans + moisturizes

scent:

floral

8.5 Fl.Oz. 125mL

A Brand By PHARMAPACKS

Purpose

Antiseptic

Warnings

For external use only.

Directions
  • Apply to hands and wet as needed.
  • Lather vigorously for at least 15 seconds.
  • Wash skin, rinse thoroughly and dry.
Questions?

Call 1-855-797-2257

Active Ingredient

Benzethonium Chloride 0.13%

Other Information (Other information)

Protect from freezing.

Avoid excessive heat.

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

Inactive Ingredients (Inactive ingredients)

Purified Water, Cocamidopropyl Betaine, Laramine Oxide, Glycerin, Cetrimonim Chloride, Fragrance, DMDM Hydantoin, Iodopropynyl Carbamate, Yellow 6, Red 4, (may contain Citric Acid, Sodium Hydroxide)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:04.225305 · Updated: 2026-03-14T22:55:59.360416