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

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

Section 55106-9

Active ingredient

Benzalkonium Chloride 0.1%

Structured Label Content

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

Warnings and Precautions (34071-1)

Warnings

For external use only

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

Section 55106-9 (55106-9)

Active ingredient

Benzalkonium Chloride 0.1%

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