SPL v1
SPL
SPL Set ID 2eab8a7f-69a0-464a-8cfa-f7bde417675f
Route
TOPICAL
Published
Effective Date 2021-02-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Water Cocamidopropyl Betaine Peg-7 Glyceryl Cocoate Propylene Glycol Edetate Sodium Phenoxyethanol Sodium Benzoate Lactic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-01-15
Description

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Benzalkonium Chloride 0.13%

Uses

For hand sanitizing to decrease bacteria on the skin

Rub together until dry without wiping

Warnings

For external use only.

When using this product: avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

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

Directions

Apply enough product to cover hands.

Rub together without wiping.

Product Label

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

Store at room temperature.

Inactive Ingredients

WATER, COCAMIDOPROPYL BETAINE, PEG-7 GLYCERYL COCOATE, PROPYLENE GLYCOL, TETRASODIUM EDTA, PHENOXYETHANOL, SODIUM BENZOATE, LACTIC ACID

Keep Out of Reach of Children

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

Structured Label Content

Uses

For hand sanitizing to decrease bacteria on the skin

Rub together until dry without wiping

Purpose

Antiseptic

Warnings

For external use only.

When using this product: avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

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

Directions

Apply enough product to cover hands.

Rub together without wiping.

Product Label (Product label)

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information (Other information)

Store at room temperature.

Inactive Ingredients (Inactive ingredients)

WATER, COCAMIDOPROPYL BETAINE, PEG-7 GLYCERYL COCOATE, PROPYLENE GLYCOL, TETRASODIUM EDTA, PHENOXYETHANOL, SODIUM BENZOATE, LACTIC ACID

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

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:22.372465 · Updated: 2026-03-14T22:59:19.689823