Drug Facts

Drug Facts

SPL v2

SPL

SPL Set ID d1045e66-e281-4127-a584-61949034b73c

Route

TOPICAL

Published

Effective Date 2013-11-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Benzalkonium (1.3 g)

Inactive Ingredients

Water Cetostearyl Alcohol Petrolatum Behenamidopropyl Dimethylamine Behenate Lauryl Laurate Glycerin Glycereth-2 Cocoate Dimethicone Benzoic Acid

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2014-01-01

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

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. If swallowed contact a doctor or Poison Control Center right away.

Section 51727-6

Water, cetearyl alcohol, petrolatum, behenamidopropyl dimethylamine lactate, lauryl laurate, glycerin, glycereth-2-cocoate, dimethicone, benzoic acid

Section 51945-4

Section 55105-1

antimicrobial

Section 55106-9

benzalkonium chloride (0.13%)

Structured Label Content

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

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

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Water, cetearyl alcohol, petrolatum, behenamidopropyl dimethylamine lactate, lauryl laurate, glycerin, glycereth-2-cocoate, dimethicone, benzoic acid

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

antimicrobial

Section 55106-9 (55106-9)

benzalkonium chloride (0.13%)

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": "CETOSTEARYL ALCOHOL", "unii": "2DMT128M1S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BEHENAMIDOPROPYL DIMETHYLAMINE BEHENATE", "unii": "96T33VV28E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LAURYL LAURATE", "unii": "GPW77G0937", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERETH-2 COCOATE", "unii": "JWM00VS7HC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZOIC ACID", "unii": "8SKN0B0MIM", "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. If swallowed contact a doctor or Poison Control Center right away.", "51727-6": "Water, cetearyl alcohol, petrolatum, behenamidopropyl dimethylamine lactate, lauryl laurate, glycerin, glycereth-2-cocoate, dimethicone, benzoic acid", "55105-1": "antimicrobial", "55106-9": "benzalkonium chloride (0.13%)"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:43.940681 · Updated: 2026-03-14T22:53:39.434183