Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID 9400334f-3337-4f23-87c2-072fdbe6a12e

Route

TOPICAL

Published

Effective Date 2011-12-13

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Benzalkonium (0.1 mL)

Inactive Ingredients

Water Cetrimonium Chloride Glycereth-2 Cocoate Behentrimonium Chloride Lactic Acid Edetate Sodium

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2011-07-27

Description

Active ingredient Benzalkonium Chloride 0.1%

Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

Uses

Hand sanitizer to help reduce bacteria on the skin that could cause disease

Recommended for repeated use.

Dosage and Administration

Directions

Pump a small amount of gel into the palm of hand

Rub thoroughly over all surfaces of both hands

Rub hands together 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, glycereth-2 cocoate, behentrimonium chloride, acrylates/diethylaminoethyl methacrylate copolymer, lactic acid, tetrasodium EDTA.

Section 51945-4

ANTIBACTERIAL HAND GEL

CLEANS IN SECONDS

KILLS 99.9% of BACTERIA

FREE from ALCOHOL

CHLORINE, FRAGRANCE and DYES

5.07fl 0z

(150ml)

Section 55105-1

Purpose

Antimicrobial

Section 55106-9

Active ingredient

Benzalkonium Chloride 0.1%

Structured Label Content

Indications and Usage (34067-9)

Uses

Hand sanitizer to help reduce bacteria on the skin that could cause disease

Recommended for repeated use.

Dosage and Administration (34068-7)

Directions

Pump a small amount of gel into the palm of hand

Rub thoroughly over all surfaces of both hands

Rub hands together 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, glycereth-2 cocoate, behentrimonium chloride, acrylates/diethylaminoethyl methacrylate copolymer, lactic acid, tetrasodium EDTA.

Section 51945-4 (51945-4)

ANTIBACTERIAL HAND GEL

CLEANS IN SECONDS

KILLS 99.9% of BACTERIA

FREE from ALCOHOL

CHLORINE, FRAGRANCE and DYES

5.07fl 0z

(150ml)

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": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETRIMONIUM CHLORIDE", "unii": "UC9PE95IBP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERETH-2 COCOATE", "unii": "JWM00VS7HC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BEHENTRIMONIUM CHLORIDE", "unii": "X7GNG3S47T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTIC ACID", "unii": "33X04XA5AT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE SODIUM", "unii": "MP1J8420LU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses Hand sanitizer to help reduce bacteria on the skin that could cause disease Recommended for repeated use.", "34068-7": "Directions Pump a small amount of gel into the palm of hand Rub thoroughly over all surfaces of both hands Rub hands together 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, glycereth-2 cocoate, behentrimonium chloride, acrylates/diethylaminoethyl methacrylate copolymer, lactic acid, tetrasodium EDTA.", "51945-4": "ANTIBACTERIAL HAND GEL CLEANS IN SECONDS KILLS 99.9% of BACTERIA FREE from ALCOHOL CHLORINE, FRAGRANCE and DYES 5.07fl 0z (150ml)", "55105-1": "Purpose Antimicrobial", "55106-9": "Active ingredient Benzalkonium Chloride 0.1%"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:22.906827 · Updated: 2026-03-14T22:52:56.035859