013fd60f-e7f0-4098-b2f8-9e75c7fcc765

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

Purpose

Antimicrobial agent

Description

Benzalkonium Chloride 0.13%

Medication Information

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.

Uses

Decreases bacteria on skin.

Purpose

Antimicrobial agent

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.

Inactive Ingredients

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

Description

Benzalkonium Chloride 0.13%

Section 50565-1

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

Active Ingredient

Benzalkonium Chloride 0.13%

Package Label Principal Display Panel

Label, 10 Wipes

Label 110 Wipes

Structured Label Content

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.

Uses

Decreases bacteria on skin.

Purpose

Antimicrobial agent

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.

Inactive Ingredients (Inactive ingredients)

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

Section 50565-1 (50565-1)

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

Active Ingredient

Benzalkonium Chloride 0.13%

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

Label, 10 Wipes

Label 110 Wipes

Advanced Ingredient Data

[{"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "1.3", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM (C12-C14)", "unii": "85440928RV", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DECYL GLUCOSIDE", "unii": "Z17H97EA6Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM ANHYDROUS", "unii": "8NLQ36F6MM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Decreases bacteria on skin.", "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": "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"}

Additional Information

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