SPL v2
SPL
SPL Set ID 39f3acca-7275-88ca-e063-6394a90ad1a2
Route
TOPICAL
Published
Effective Date 2025-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.005 g)
Inactive Ingredients
1,2,3-propanetriol, 2-(4-aminobenzoate) Phenoxyethanol 3-isopropylamino-1,2-propanediol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-01
Description

Benzalkonium Chloride

Medication Information

Warnings and Precautions

For external use only, Stop use and consult doctor if skin irritation develops.

Indications and Usage

Clean and refreshes hands without soap and water.

Dosage and Administration

Directions: Tear open, unfold and apply to hands.

Description

Benzalkonium Chloride

Section 44425-7

Store in cool place.

Section 50565-1

Keep out of reach of children.

Section 50566-9

For external use only, Stop use and consult doctor if skin irritation develops.

Section 50567-7

When using this product keep out of eyes.

Section 50570-1

When using this product do not use in ornear the eyes.In case of contact, rinse eyes thoroughly with water.

Section 51727-6

Deionized water, Glycerol, 1,2-propanediol, 2-phenoxyetanol, Didecyl dimethyl ammonium chloride, 2-propandiol, Antibacterial synerists, Stabilizer.

Section 51945-4

Section 55105-1

Clean and refreshes hands without soap and water.

Section 55106-9

Benzalkonium Chloride

Structured Label Content

Indications and Usage (34067-9)

Clean and refreshes hands without soap and water.

Dosage and Administration (34068-7)

Directions: Tear open, unfold and apply to hands.

Warnings and Precautions (34071-1)

For external use only, Stop use and consult doctor if skin irritation develops.

Section 44425-7 (44425-7)

Store in cool place.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

For external use only, Stop use and consult doctor if skin irritation develops.

Section 50567-7 (50567-7)

When using this product keep out of eyes.

Section 50570-1 (50570-1)

When using this product do not use in ornear the eyes.In case of contact, rinse eyes thoroughly with water.

Section 51727-6 (51727-6)

Deionized water, Glycerol, 1,2-propanediol, 2-phenoxyetanol, Didecyl dimethyl ammonium chloride, 2-propandiol, Antibacterial synerists, Stabilizer.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Clean and refreshes hands without soap and water.

Section 55106-9 (55106-9)

Benzalkonium Chloride

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:05.853826 · Updated: 2026-03-14T23:12:14.139281