SPL v1
SPL
SPL Set ID adc00888-033c-d9a1-e053-2995a90a7d97
Route
TOPICAL
Published
Effective Date 2020-04-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (13 mg)
Inactive Ingredients
Hydroxyethyl Cellulose, Unspecified Glycerin Water Methylparaben Propylparaben Dmdm Hydantoin Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-24
Description

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Benzalkonium Chloride 0.13%

Use

Hand sanitizer to help reduce bacteria that can potencially cause disease.

For use when soap and water are not available.

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if irritation or rash occurs.

These may be signs of a serious condition.

Section 50567-7

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

Section 51945-4

Warnings

Do not freeze. For external use only.

Do Not Use
  • In children less than 2 months of age
  • On open skin wounds.
Directions
  • Place just one drop on hands to cover all surfaces.
Other Information
  • Store below 110F (43C)
  • May discolor certain fabrics or surfaces
Active Ingredients

Benzalkonium Chloride 0.13%

Inactive Ingredients

Water, hyroxyethyl cellulose, glycerin, methylparaben, propylene glycol, DMDM H

Structured Label Content

Use

Hand sanitizer to help reduce bacteria that can potencially cause disease.

For use when soap and water are not available.

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash occurs.

These may be signs of a serious condition.

Section 50567-7 (50567-7)

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

Section 51945-4 (51945-4)

Purpose

Antimicrobial

Warnings (WARNINGS)

Do not freeze. For external use only.

Do Not Use (DO NOT USE)
  • In children less than 2 months of age
  • On open skin wounds.
Directions
  • Place just one drop on hands to cover all surfaces.
Other Information (OTHER INFORMATION)
  • Store below 110F (43C)
  • May discolor certain fabrics or surfaces
Active Ingredients

Benzalkonium Chloride 0.13%

Inactive Ingredients (INACTIVE INGREDIENTS)

Water, hyroxyethyl cellulose, glycerin, methylparaben, propylene glycol, DMDM H

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:34.549090 · Updated: 2026-03-14T22:58:10.333472