SPL v2
SPL
SPL Set ID a735bf12-36f8-89b4-e053-2995a90a563e
Route
TOPICAL
Published
Effective Date 2020-06-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.1 g)
Inactive Ingredients
Lauramine Oxide Peg-120 Methyl Glucose Dioleate Water Glycerin

Identifiers & Packaging

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

Benzalkonium Chloride 0.1%

Purpose

Skin Antimicrobial

Medication Information

Purpose

Skin Antimicrobial

Description

Benzalkonium Chloride 0.1%

Use

Reduces amount of bacteria on hands

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Section 50567-7

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Section 51945-4

Warnings

For external use only.

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop Use and Ask a Doctor of irritation or redness develops, or if condition persists for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply a palmful to hands and forearms.

Scrub thoroughly for at least fifteen seconds

Rinse completely and dry.

Active Ingredient

Benzalkonium Chloride 0.1%

Inactive Ingredients

Water, Lauramine Oxide, Glycerin, PEG-120 Methyl Glucose Dioleate, Fragrance

Structured Label Content

Use

Reduces amount of bacteria on hands

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 50566-9 (50566-9)

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Section 51945-4 (51945-4)

Purpose

Skin Antimicrobial

Warnings

For external use only.

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop Use and Ask a Doctor of irritation or redness develops, or if condition persists for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply a palmful to hands and forearms.

Scrub thoroughly for at least fifteen seconds

Rinse completely and dry.

Active Ingredient

Benzalkonium Chloride 0.1%

Inactive Ingredients

Water, Lauramine Oxide, Glycerin, PEG-120 Methyl Glucose Dioleate, Fragrance

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:48.164449 · Updated: 2026-03-14T22:57:05.210150