SPL v3
SPL
SPL Set ID ab26830a-5d7d-7cdb-e053-2a95a90a4cb8
Route
TOPICAL
Published
Effective Date 2020-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.1 mg)
Inactive Ingredients
Water Polyaminopropyl Biguanide Propylene Glycol Glycerin Phenoxyethanol Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-23
Description

BENZALKONIUM CHLORIDE 0.1%

Purpose

Purpose: Antimicrobial

Medication Information

Purpose

Purpose: Antimicrobial

Description

BENZALKONIUM CHLORIDE 0.1%

Use

Hand Sanitizer to help reduce bacteria on the skin

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.

Warnings

For external use only. Flammable. Keep away from heat or flame

Directions
  • Wet hands thoroughly with product and allow to dry.
  • Discard wipes in trash receptacle after use. Do not flush
  • Children under 6 years of age should be supervised when using this product.
Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient(s)

BENZALKONIUM CHLORIDE 0.1%

Inactive Ingredients

Ethylhexylglycerin, Glycerin, Phenoxyethanol, Polyaminopropyl biguanide, Propylene Glycol, Purified water

Package Label Principal Display Panel

10 mL NDC: 79438-002-10

75 mL NDC: 79438-002-75

50 mL NDC: 79438-002-50

Structured Label Content

Use

Hand Sanitizer to help reduce bacteria on the 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.

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.

Purpose

Purpose: Antimicrobial

Warnings

For external use only. Flammable. Keep away from heat or flame

Directions
  • Wet hands thoroughly with product and allow to dry.
  • Discard wipes in trash receptacle after use. Do not flush
  • Children under 6 years of age should be supervised when using this product.
Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient(s)

BENZALKONIUM CHLORIDE 0.1%

Inactive Ingredients (Inactive ingredients)

Ethylhexylglycerin, Glycerin, Phenoxyethanol, Polyaminopropyl biguanide, Propylene Glycol, Purified water

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

10 mL NDC: 79438-002-10

75 mL NDC: 79438-002-75

50 mL NDC: 79438-002-50

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:32.415402 · Updated: 2026-03-14T22:58:06.962272