Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID 2618ecdc-3eeb-a69b-e063-6394a90a8024

Route

TOPICAL

Published

Effective Date 2024-11-11

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Benzalkonium (0.13 g)

Inactive Ingredients

Phenoxyethanol Citric Acid Monohydrate Water Tetrasodium Edta Cetrimonium Chloride

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-11-04

Description

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Uses

Hand wash to help reduce bacteria on skin
Recommended for repeated use

Section 50565-1

Keep out of reach of children. If swallowed, call a physician or Poison Control Center immediately.

Section 50566-9

If irritation or rash appears and persists, stop use and see a physician.

Section 50567-7

When using this product do not use in or near eyes.

If in eyes, flush thoroughly with water.

Section 51945-4

Low Profile

ALTRA

Antimicrobial

Foaming

Hand Wash

w/ Benzalkonium Chloride

Hand Hygiene

NET CONTENTS 1000 mL (33.8 fl oz)

Warnings

For external use only.

Directions

Wet hands and wrists
Dispense an adequate amount of soap and vigorously wash hands
Rinse hands thoroughly with clean or potable water
Dry hands completely

Questions?

Call: Buckeye International, Inc. 314-291-1900

Monday through Friday 8:00 a.m. to 5:00 p.m. CST

Active Ingredient

Benzalkonium Chloride 0.13%

Inactive Ingredients

Water (Aqua), Cetrimonium Chloride, Tetrasodium EDTA, Phenoxyethanol, Citric Acid.

Structured Label Content

Uses

Hand wash to help reduce bacteria on skin
Recommended for repeated use

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, call a physician or Poison Control Center immediately.

Section 50566-9 (50566-9)

If irritation or rash appears and persists, stop use and see a physician.

Section 50567-7 (50567-7)

When using this product do not use in or near eyes.

If in eyes, flush thoroughly with water.

Section 51945-4 (51945-4)

Low Profile

ALTRA

Antimicrobial

Foaming

Hand Wash

w/ Benzalkonium Chloride

Hand Hygiene

NET CONTENTS 1000 mL (33.8 fl oz)

Purpose

Antibacterial

Warnings

For external use only.

Directions

Wet hands and wrists
Dispense an adequate amount of soap and vigorously wash hands
Rinse hands thoroughly with clean or potable water
Dry hands completely

Questions?

Call: Buckeye International, Inc. 314-291-1900

Monday through Friday 8:00 a.m. to 5:00 p.m. CST

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Cetrimonium Chloride, Tetrasodium EDTA, Phenoxyethanol, Citric Acid.

Advanced Ingredient Data

[{"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.13", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TETRASODIUM EDTA", "unii": "MP1J8420LU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETRIMONIUM CHLORIDE", "unii": "UC9PE95IBP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Hand wash to help reduce bacteria on skin Recommended for repeated use", "50565-1": "Keep out of reach of children. If swallowed, call a physician or Poison Control Center immediately.", "50566-9": "If irritation or rash appears and persists, stop use and see a physician.", "50567-7": "When using this product do not use in or near eyes. If in eyes, flush thoroughly with water.", "51945-4": "Low Profile ALTRA Antimicrobial Foaming Hand Wash w/ Benzalkonium Chloride Hand Hygiene NET CONTENTS 1000 mL (33.8 fl oz)", "Purpose": "Antibacterial", "Warnings": "For external use only.", "Directions": "Wet hands and wrists Dispense an adequate amount of soap and vigorously wash hands Rinse hands thoroughly with clean or potable water Dry hands completely", "Questions?": "Call: Buckeye International, Inc. 314-291-1900 Monday through Friday 8:00 a.m. to 5:00 p.m. CST", "Active ingredient": "Benzalkonium Chloride 0.13%", "Inactive ingredients": "Water (Aqua), Cetrimonium Chloride, Tetrasodium EDTA, Phenoxyethanol, Citric Acid."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:13.083992 · Updated: 2026-03-14T23:04:48.319278