drug facts

drug facts

SPL v1

SPL

SPL Set ID 38fe13b1-22ae-44fb-b67a-ed9b66723bd1

Route

topical

Published

Effective Date 2014-07-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

benzalkonium (1.3 g)

Inactive Ingredients

water cetrimonium chloride citric acid monohydrate dihydroxyethyl cocamine oxide glycereth-17 cocoate laurtrimonium chloride

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2014-07-02

Description

Benzalkonium chloride 0.13%

Medication Information

Warnings and Precautions

For external use only

Do not use in or near the eyes

Stop use and ask a doctor if irritation or rash appears and lasts

Keep out of reach of children. If swallowed contact a doctor or Poison Control Center right away

Active Ingredient

Benzalkonium chloride 0.13%

Indications and Usage

Hand sanitizer to help reduce bacteria on the skin

Dosage and Administration

Wet hands thoroughly with product and allow to dry without wiping

Description

Benzalkonium chloride 0.13%

Section 50565-1

Keep out of reach of children

Section 51727-6

Water, cetrimonium chloride, citric acid, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, laurtrimonium chloride

Section 55105-1

Antimicrobial

Nonalcohol

nonalcohol

Structured Label Content

Warnings and Precautions (34071-1)

For external use only

Do not use in or near the eyes

Stop use and ask a doctor if irritation or rash appears and lasts

Keep out of reach of children. If swallowed contact a doctor or Poison Control Center right away

Active Ingredient (55106-9)

Benzalkonium chloride 0.13%

Indications and Usage (34067-9)

Hand sanitizer to help reduce bacteria on the skin

Dosage and Administration (34068-7)

Wet hands thoroughly with product and allow to dry without wiping

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Water, cetrimonium chloride, citric acid, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, laurtrimonium chloride

Section 55105-1 (55105-1)

Antimicrobial

Nonalcohol (nonalcohol)

nonalcohol

Advanced Ingredient Data

[{"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "1.3", "strengthDenominator": "1000", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETRIMONIUM CHLORIDE", "unii": "UC9PE95IBP", "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": "GLYCERETH-17 COCOATE", "unii": "3057VPT0KC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LAURTRIMONIUM CHLORIDE", "unii": "A81MSI0FIC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Hand sanitizer to help reduce bacteria on the skin", "34068-7": "Wet hands thoroughly with product and allow to dry without wiping", "34071-1": "For external use only Do not use in or near the eyes Stop use and ask a doctor if irritation or rash appears and lasts Keep out of reach of children. If swallowed contact a doctor or Poison Control Center right away", "50565-1": "Keep out of reach of children", "51727-6": "Water, cetrimonium chloride, citric acid, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, laurtrimonium chloride", "55105-1": "Antimicrobial", "55106-9": "Benzalkonium chloride 0.13%", "nonalcohol": "nonalcohol"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:48.793742 · Updated: 2026-03-14T22:53:46.796959