SPL v2
SPL
SPL Set ID edba867d-6480-4543-a6b2-1bfb12bc3cae
Route
TOPICAL
Published
Effective Date 2016-07-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (.1 g)
Inactive Ingredients
Water Propylene Glycol Cocamidopropyl Betaine Polyaminopropyl Biguanide Aloe Vera Leaf .alpha.-tocopherol Acetate Peg-54 Hydrogenated Castor Oil Edetate Disodium Citric Acid Monohydrate Methylchloroisothiazolinone Methyl Soyate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-07-26
Description

Active ingredient Benzalkonium chloride 0.115%

Medication Information

Warnings and Precautions

Warnings

For external use only

Do not use

-over large areas of the body if you are allergic to any of the ingredients

When using this product avoid contact with eyes and face.

If contact occurs, flush thoroughly with water.

Stop use and ask a doctor if irritation or rash develops and

continues for more than 72 hours

Indications and Usage

Use   decreases bacteria on skin

Dosage and Administration

Directions

-for adults and children of 2 years and over use

on hands and face to clean and refresh, allow skin to air dry.

-For children under 2 years ask a doctor before using

Description

Active ingredient Benzalkonium chloride 0.115%

Section 50565-1

Keep out of reach of children. If swallowed, get medical

help or contact a Poison Control Center right away

Section 51727-6

Inactive ingredient

Water, propylene glycol, glycerin, cocamidopropyl

betaine, polyaminopropyl biguanide, aloe barbadensis leaf extract,

tocopheryl acetate, peg-54 hydrigenated castor oil, disodium edta,

citric acid, fragrance, methylchloroisothiazolinone,

methylsothiazolinone

Section 51945-4

Section 55105-1

Purpose

Antibacterial

Section 55106-9

Active ingredient

Benzalkonium chloride 0.115%

Structured Label Content

Indications and Usage (34067-9)

Use   decreases bacteria on skin

Dosage and Administration (34068-7)

Directions

-for adults and children of 2 years and over use

on hands and face to clean and refresh, allow skin to air dry.

-For children under 2 years ask a doctor before using

Warnings and Precautions (34071-1)

Warnings

For external use only

Do not use

-over large areas of the body if you are allergic to any of the ingredients

When using this product avoid contact with eyes and face.

If contact occurs, flush thoroughly with water.

Stop use and ask a doctor if irritation or rash develops and

continues for more than 72 hours

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 51727-6 (51727-6)

Inactive ingredient

Water, propylene glycol, glycerin, cocamidopropyl

betaine, polyaminopropyl biguanide, aloe barbadensis leaf extract,

tocopheryl acetate, peg-54 hydrigenated castor oil, disodium edta,

citric acid, fragrance, methylchloroisothiazolinone,

methylsothiazolinone

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Antibacterial

Section 55106-9 (55106-9)

Active ingredient

Benzalkonium chloride 0.115%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:08.653292 · Updated: 2026-03-14T22:54:23.335310