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.

Active Ingredient

Active ingredient

Benzalkonium Chloride 0.1%

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

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

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.

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

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

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