54622-317

54622-317
SPL v2
SPL
SPL Set ID fe1727b4-b016-74fc-e053-6394a90ad78a
Route
TOPICAL
Published
Effective Date 2023-06-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Fd&c Red No. 40 Water .alpha.-tocopherol, Dl- Edetate Sodium Sodium Pidolate Oleth-10 Fd&c Yellow No. 6 Glycerin Laurtrimonium Chloride Anhydrous Citric Acid Lauryl Betaine Lauramine Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-14
Description

Drug Facts

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Drug Facts

Use

Handwash to help reduce bacteria that potentially can cause disease.

Section 42229-5

Drug Facts

Section 51945-4

Stop Use

if irritation or redness develops. If condition persists for more than 72 hours consult a doctor.

Warnings
  • For external use only
directions

Wet hands, apply soap, rub hands together vigorously for at least 20 seconds.

Rinse and dry hands thoroughly with a disposable paper towel.

Active Ingredient

Benzalkonium chloride, 0.13% w/w

inactive Ingredients

Water (Aqua), Lauramine Oxide, Lauryl Betaine, Laurtrimonium

Chloride, Glycerin, Sodium PCA, Tocopheryl Acetate,

Oleth-10, Tetrasodium EDTA, Citric Acid, Fragrance,

FD&C Yellow #6, FD&C Red #40

when Using This Product

Avoid contact with eyes. In case of eye contact, flush with water.

keep Out of Reach of Children.

If swallowed, seek immediate medical attention or call a poison control center.

Structured Label Content

Use

Handwash to help reduce bacteria that potentially can cause disease.

Section 42229-5 (42229-5)

Drug Facts

Section 51945-4 (51945-4)

Purpose

Antiseptic

Stop Use (Stop use)

if irritation or redness develops. If condition persists for more than 72 hours consult a doctor.

Warnings
  • For external use only
directions (Directions)

Wet hands, apply soap, rub hands together vigorously for at least 20 seconds.

Rinse and dry hands thoroughly with a disposable paper towel.

Active Ingredient (Active ingredient)

Benzalkonium chloride, 0.13% w/w

inactive Ingredients (Inactive ingredients)

Water (Aqua), Lauramine Oxide, Lauryl Betaine, Laurtrimonium

Chloride, Glycerin, Sodium PCA, Tocopheryl Acetate,

Oleth-10, Tetrasodium EDTA, Citric Acid, Fragrance,

FD&C Yellow #6, FD&C Red #40

when Using This Product (When using this product)

Avoid contact with eyes. In case of eye contact, flush with water.

keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, seek immediate medical attention or call a poison control center.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:02.674230 · Updated: 2026-03-14T23:02:54.359020