ee8be683-f935-b32b-e053-2995a90aa51f

SPL v2

SPL

SPL Set ID ee8be683-f935-b32b-e053-2995a90aa51f

Route

topical

Published

Effective Date 2022-12-31

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

benzalkonium (1 g)

Inactive Ingredients

water fragrance 13576 citric acid monohydrate dihydroxyethyl cocamine oxide cetrimonium chloride laurtrimonium chloride cocamidopropyl pg-dimonium chloride phosphate

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2022-12-31

Purpose

Antiseptic

Description

Benzalkonium Chloride 0.1% w/w

Medication Information

Warnings

For external use only.

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation and redness develops, if condition persists for more than 72 hours consult a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Purpose

Antiseptic

Directions

Pump a small amount of foam into palm of hand

Rub thoroughly over all surfaces of both hands

Rub hands together briskly until dry

Inactive Ingredients

Water, Cocomidopropyl PG-Dimonium Chloride Phosphate, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Citric Acid, Fragrance

Description

Benzalkonium Chloride 0.1% w/w

Questions?

1-800-537-8990

Use

For hand sanitizing to decrease bacteria on the skin
Recommended for repeated use

Section 51945-4

Warnings Section

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away

Active Ingredient

Benzalkonium Chloride 0.1% w/w

Structured Label Content

Warnings

For external use only.

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation and redness develops, if condition persists for more than 72 hours consult a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Purpose

Antiseptic

Directions

Pump a small amount of foam into palm of hand

Rub thoroughly over all surfaces of both hands

Rub hands together briskly until dry

Inactive Ingredients

Water, Cocomidopropyl PG-Dimonium Chloride Phosphate, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Citric Acid, Fragrance

Questions?

1-800-537-8990

Use

For hand sanitizing to decrease bacteria on the skin
Recommended for repeated use

Section 51945-4 (51945-4)

Warnings Section

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away

Active Ingredient

Benzalkonium Chloride 0.1% w/w

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FRAGRANCE 13576", "unii": "5EM498GW35", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIHYDROXYETHYL COCAMINE OXIDE", "unii": "8AR51R3BL5", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETRIMONIUM CHLORIDE", "unii": "UC9PE95IBP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1000", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "LAURTRIMONIUM CHLORIDE", "unii": "A81MSI0FIC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE", "unii": "H2KVQ74JM4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "For hand sanitizing to decrease bacteria on the skin Recommended for repeated use", "Purpose": "Antiseptic", "Warnings": "For external use only. When using this product avoid contact with eyes. In case of eye contact, flush eyes with water. Stop use and ask a doctor if irritation and redness develops, if condition persists for more than 72 hours consult a doctor. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.", "Directions": "Pump a small amount of foam into palm of hand Rub thoroughly over all surfaces of both hands Rub hands together briskly until dry", "Questions?": "1-800-537-8990", "Warnings Section": "Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away", "Active Ingredient": "Benzalkonium Chloride 0.1% w/w", "Inactive Ingredients": "Water, Cocomidopropyl PG-Dimonium Chloride Phosphate, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Citric Acid, Fragrance"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:32.791082 · Updated: 2026-03-14T23:02:10.811423