ab26830a-5d7d-7cdb-e053-2a95a90a4cb8

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

Purpose

Purpose: Antimicrobial

Description

BENZALKONIUM CHLORIDE 0.1%

Medication Information

Warnings

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

Purpose

Purpose: Antimicrobial

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.

Inactive Ingredients

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

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.

Do Not Use

in children less than 2 months of age
on open skin wounds

Active Ingredient(s)

BENZALKONIUM CHLORIDE 0.1%

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

Warnings

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

Purpose

Purpose: Antimicrobial

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.

Inactive Ingredients (Inactive ingredients)

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

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.

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%

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

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYAMINOPROPYL BIGUANIDE", "unii": "DT9D8Z79ET", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.1", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLHEXYLGLYCERIN", "unii": "147D247K3P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "Hand Sanitizer to help reduce bacteria on the skin", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.", "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": "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"}

Additional Information

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