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

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. 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

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. 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

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

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