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
Description

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

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.

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.

Directions

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

Active Ingredient

Benzalkonium chloride 0.13%

Inactive Ingredients

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

Package Label Principal Display Panel

Structured Label Content

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.

Purpose

Antiseptic

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.

Directions

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

Active Ingredient

Benzalkonium chloride 0.13%

Inactive Ingredients (Inactive ingredients)

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

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