SPL v1
SPL
SPL Set ID a1a6de6b-7fc4-6d0f-e053-2a95a90a13c7
Route
TOPICAL
Published
Effective Date 2020-03-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.1 g)
Inactive Ingredients
Aloe Vera Leaf .alpha.-tocopherol Acetate Cupric Bis(triethanolamine) 2-bromo-2-nitroethanol Water Disodium Edta-copper Sodium Lauryl Sulfate Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-16
Description

Benzalkonium chloride 0.1%

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Benzalkonium chloride 0.1%

Use

decreases bacteria on skin

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact aPoisonControlCenter right away.

Section 51945-4

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.

Directions

For adults and children of 2 years and over.

Children under 2 years ask a doctor before use.

Allow to dry without wiping.

Active Ingredient

Benzalkonium chloride 0.1%

Inactive Ingredients

water,sodium lauryl sulfate,fragrance,2-bromo-2-nitropropane-1,3-diol,aloe barbadensis leaf extract,disodium EDTA,trithanolamine ,glycerin,tocopheryl acetate

Structured Label Content

Use

decreases bacteria on skin

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact aPoisonControlCenter right away.

Section 51945-4 (51945-4)

Purpose

Antibacterial

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.

Directions

For adults and children of 2 years and over.

Children under 2 years ask a doctor before use.

Allow to dry without wiping.

Active Ingredient

Benzalkonium chloride 0.1%

Inactive Ingredients

water,sodium lauryl sulfate,fragrance,2-bromo-2-nitropropane-1,3-diol,aloe barbadensis leaf extract,disodium EDTA,trithanolamine ,glycerin,tocopheryl acetate

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:24.734596 · Updated: 2026-03-14T22:56:34.499802