SPL v3
SPL
SPL Set ID a5aafa28-7c3e-0f9d-e053-2995a90a4027
Route
TOPICAL
Published
Effective Date 2020-05-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Iodopropynyl Butylcarbamate Polysorbate 20 Glycerin Water Bronopol Aloe Vera Leaf Propylene Glycol .alpha.-tocopherol Acetate, Dl- Fragrance Lavender & Chia F-153480

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-05-16
Description

Drug Facts

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Drug Facts

Use

For hand washing to decrease bacteria on the skin.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children except with adult supervision.

Section 50566-9

Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours.

Section 50567-7

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

Warnings

For external use only.

Directions

Open packet,remove and unfold pre-moistened tissue.

Wipe hand including nails and cuticles

Allow to dry without wiping.

Discard properly after use.

Do not flush down toilet.

Other Information

Store at room temperature.

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Inactive Ingredients

Aloe barbadensis leaf extract，Aqua，2-Bromo-2-Nitropropane-1,3-Diol，Fragrance，Glycerin，IodopropynylButylcarbamate，Polysorbate 20，Propylene Glycol，Tocopheryl Acetate

Package Label Principal Display Panel

Structured Label Content

Use

For hand washing to decrease bacteria on the skin.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children except with adult supervision.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours.

Section 50567-7 (50567-7)

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

Purpose

Antibacterial

Warnings

For external use only.

Directions

Open packet,remove and unfold pre-moistened tissue.

Wipe hand including nails and cuticles

Allow to dry without wiping.

Discard properly after use.

Do not flush down toilet.

Other Information (Other information)

Store at room temperature.

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Inactive Ingredients (Inactive ingredients)

Aloe barbadensis leaf extract，Aqua，2-Bromo-2-Nitropropane-1,3-Diol，Fragrance，Glycerin，IodopropynylButylcarbamate，Polysorbate 20，Propylene Glycol，Tocopheryl Acetate

Package Label Principal Display Panel (Package Label - Principal Display Panel)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:23.622151 · Updated: 2026-03-14T23:01:53.224533