5c762901-9652-449a-b2a0-85e71c12beef

SPL v1
SPL
SPL Set ID 5c762901-9652-449a-b2a0-85e71c12beef
Route
topical
Published
Effective Date 2020-05-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (0.13 g)
Inactive Ingredients
water isopropyl alcohol hydroxyethyl cellulose, unspecified glycerin methylparaben propylparaben propylene glycol dmdm hydantoin fd&c blue no. 1

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-05-12
Purpose

Antiseptic

Description

Benzalkonium chloride 0.13%

Medication Information

Warnings

Do not freeze. For external use only.

Do not use

  • in children less than 2 months of age
  • in ears or mouth

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Purpose

Antiseptic

Directions

Apply a small amount into palms and spread on both hands. Rub into skin until dry.

Inactive Ingredients

Isopropyl alcohol, Hydroxyethyl celleulose, glycerin, methylparaben, propylparaben, Propylene glycol, Dmdm hydantoin, FD&C Blue no 1

Description

Benzalkonium chloride 0.13%

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 50565-1

Keep out of reach of children.

Children should be supervised when using this product.

Active Ingredient

Benzalkonium chloride 0.13%

Package Label Principal Display Panel

Structured Label Content

Warnings

Do not freeze. For external use only.

Do not use

  • in children less than 2 months of age
  • in ears or mouth

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Purpose

Antiseptic

Directions

Apply a small amount into palms and spread on both hands. Rub into skin until dry.

Inactive Ingredients (Inactive ingredients)

Isopropyl alcohol, Hydroxyethyl celleulose, glycerin, methylparaben, propylparaben, Propylene glycol, Dmdm hydantoin, FD&C Blue no 1

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 50565-1 (50565-1)

Keep out of reach of children.

Children should be supervised when using this product.

Active Ingredient

Benzalkonium chloride 0.13%

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: 2026-02-15T11:57:30.438907 · Updated: 2026-03-14T22:56:42.417712