drug facts

drug facts

SPL v1

SPL

SPL Set ID 32744d9c-c381-473d-8820-f909b73f1bfa

Route

topical

Published

Effective Date 2019-02-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

benzalkonium (0.1 g)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2019-02-20

Description

Active ingredient Benzalkonium Chloride 0.1%

Medication Information

Warnings and Precautions

Warnings

For external use only

Active Ingredient

Active ingredient

Benzalkonium Chloride 0.1%

Indications and Usage

Uses

for hand sanitizing to decrease bacteria on the skin

recommended for repeated use

Dosage and Administration

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

Description

Active ingredient Benzalkonium Chloride 0.1%

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 redness develops, or if condition persists for more than 72 hours.

Section 50567-7

When using this product avoid contact with eyes.

In case of eye contact, flush eyes with water.

Section 51727-6

Inactive ingredients

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

Section 51945-4

puracy

NATURAL FOAMING

HAND SANITIZER

alcohol-free kills 99.9% of germs

FRAGRANCE FREE

Austin Texas 8.5 fl.oz. (251 mL)

Section 55105-1

Purpose

Antimicrobial

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only

Active Ingredient (55106-9)

Active ingredient

Benzalkonium Chloride 0.1%

Indications and Usage (34067-9)

Uses

for hand sanitizing to decrease bacteria on the skin

recommended for repeated use

Dosage and Administration (34068-7)

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

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 redness develops, or if condition persists for more than 72 hours.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes.

In case of eye contact, flush eyes with water.

Section 51727-6 (51727-6)

Inactive ingredients

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

Section 51945-4 (51945-4)

puracy

NATURAL FOAMING

HAND SANITIZER

alcohol-free kills 99.9% of germs

FRAGRANCE FREE

Austin Texas 8.5 fl.oz. (251 mL)

Section 55105-1 (55105-1)

Purpose

Antimicrobial

Advanced Ingredient Data

[{"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETRIMONIUM CHLORIDE", "unii": "UC9PE95IBP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LAURTRIMONIUM CHLORIDE", "unii": "A81MSI0FIC", "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": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses for hand sanitizing to decrease bacteria on the skin recommended for repeated use", "34068-7": "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", "34071-1": "Warnings For external use only", "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 redness develops, or if condition persists for more than 72 hours.", "50567-7": "When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.", "51727-6": "Inactive ingredients Water, cetrimonium chloride, laurtrimonium chloride, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, citric acid", "51945-4": "puracy NATURAL FOAMING HAND SANITIZER alcohol-free kills 99.9% of germs FRAGRANCE FREE Austin Texas 8.5 fl.oz. (251 mL)", "55105-1": "Purpose Antimicrobial", "55106-9": "Active ingredient Benzalkonium Chloride 0.1%"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:45.593740 · Updated: 2026-03-14T22:55:26.303656