SPL v1
SPL
SPL Set ID da162393-9f82-4bc9-9fa3-75b0d257a314
Route
TOPICAL
Published
Effective Date 2016-06-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (.1 g)
Inactive Ingredients
Water Polysorbate 20 Phenoxyethanol Polyaminopropyl Biguanide Aloe Vera Leaf Bronopol Disodium Edta-copper Glycerin .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-06-15
Description

Active ingredient Benzalkonium chloride 0.1%

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

-children under 2 years ask a doctor before using

-allow to dry without wiping

Description

Active ingredient Benzalkonium chloride 0.1%

Section 44425-7

Other information  store at room temperature

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, Glycerin, Phenoxyethanol, Polysorbate 20, Aloe Barabdensis

Leaf Extract, Polyaminopropyl Biguianide, Disodium EDTA,

Fragrance, 2-Bromo-2 Nitroporpane 1,3 Diol, Tocopheryl Acetate

Section 51945-4

Section 55105-1

Purpose

Antibacterial

Section 55106-9

Active ingredient

Benzalkonium chloride 0.1%

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

-children under 2 years ask a doctor before using

-allow to dry without wiping

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 44425-7 (44425-7)

Other information  store at room temperature

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, Glycerin, Phenoxyethanol, Polysorbate 20, Aloe Barabdensis

Leaf Extract, Polyaminopropyl Biguianide, Disodium EDTA,

Fragrance, 2-Bromo-2 Nitroporpane 1,3 Diol, Tocopheryl Acetate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Antibacterial

Section 55106-9 (55106-9)

Active ingredient

Benzalkonium chloride 0.1%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:08.020271 · Updated: 2026-03-14T22:54:21.601813