54622-313

54622-313
SPL v2
SPL
SPL Set ID c8d09207-d152-5abc-e053-2a95a90aaf92
Route
TOPICAL
Published
Effective Date 2021-08-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-08-05
Description

Benzalkonium chloride, 0.13%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Benzalkonium chloride, 0.13%

Use

Handwash to help reduce bacteria that potentially can cause disease.

Section 51945-4

Stop Use

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

Warnings

For external use only

Directions

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

Rinse and dry hands thoroughly.

Active Ingredient

Benzalkonium chloride, 0.13%

Inactive Ingredients

Water (Aqua), Lauramine Oxide, Lauryl Betaine, Glycerin, Laurtrimonium Chloride, Sodium PCA, Tocopheryl Acetate, Oleth-10, Tetrasodium EDTA, Citric Acid, Red 40, Yellow 6, Fragrance

When Using This Product

Avoid contact with the 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 51945-4 (51945-4)

Purpose

Antiseptic

Stop Use (Stop use)

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

Warnings

For external use only

Directions

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

Rinse and dry hands thoroughly.

Active Ingredient (Active ingredient)

Benzalkonium chloride, 0.13%

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Lauramine Oxide, Lauryl Betaine, Glycerin, Laurtrimonium Chloride, Sodium PCA, Tocopheryl Acetate, Oleth-10, Tetrasodium EDTA, Citric Acid, Red 40, Yellow 6, Fragrance

When Using This Product (When using this product)

Avoid contact with the 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: 2026-02-15T12:03:02.644407 · Updated: 2026-03-14T23:02:54.359020