SPL v2
SPL
SPL Set ID 013fd60f-e7f0-4098-b2f8-9e75c7fcc765
Route
TOPICAL
Published
Effective Date 2020-05-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 g)
Inactive Ingredients
N-alkyl Ethylbenzyl Dimethyl Ammonium (c12-c14) Decyl Glucoside Edetate Disodium Anhydrous Propylene Glycol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-10
Description

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial agent

Medication Information

Purpose

Antimicrobial agent

Description

Benzalkonium Chloride 0.13%

Uses

Decreases bacteria on skin.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only.

Do not use if you are allergic to any of the ingredients.

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

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

Directions

Open lid and remove wipes.

Wet hands thoroughly with product and let hands air dry.

Throw used wipe in trash.

Do not flush.

 Adults and children 2 years and over:  Apply to hands. allow hands to dry without wiping.
 Children under 2 years:  Ask a doctor before use.

Active Ingredient

Benzalkonium Chloride 0.13%

Inactive Ingredients

c12-14 Alkyl Dymethyl, Ethylbenzyl Ammonium Chloride, Alkyl Polyglucoside, Disodium EDTA, Propylene glycol, Aqua

Package Label Principal Display Panel

Label, 10 Wipes

Label 110 Wipes

Structured Label Content

Uses

Decreases bacteria on skin.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Antimicrobial agent

Warnings

For external use only.

Do not use if you are allergic to any of the ingredients.

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

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

Directions

Open lid and remove wipes.

Wet hands thoroughly with product and let hands air dry.

Throw used wipe in trash.

Do not flush.

 Adults and children 2 years and over:  Apply to hands. allow hands to dry without wiping.
 Children under 2 years:  Ask a doctor before use.

Active Ingredient

Benzalkonium Chloride 0.13%

Inactive Ingredients (Inactive ingredients)

c12-14 Alkyl Dymethyl, Ethylbenzyl Ammonium Chloride, Alkyl Polyglucoside, Disodium EDTA, Propylene glycol, Aqua

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

Label, 10 Wipes

Label 110 Wipes

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:50.764188 · Updated: 2026-03-14T22:57:07.300794