Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 24204b66-c56d-4709-864a-ff6704027d31
Route
TOPICAL
Published
Effective Date 2015-06-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Water Cetrimonium Chloride Glycerin Lauramidopropylamine Oxide Coco Monoethanolamide Sodium Chloride Peg-120 Methyl Glucose Dioleate Citric Acid Monohydrate Edetate Sodium Sodium Sulfate Methylchloroisothiazolinone Methylisothiazolinone Fd&c Red No. 40 Fd&c Yellow No. 5 D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-06-17
Description

BENZALKONIUM CHLORIDE 0.13%

Purpose

ANTIBACTERIAL

Medication Information

Purpose

ANTIBACTERIAL

Description

BENZALKONIUM CHLORIDE 0.13%

Uses

HELPS ELIMINATE BACTERIA ON HANDS

Warnings

FOR EXTERNAL USE ONLY

Directions
  • USE AS A REFILL FOR A PUMP DISPENSING BOTTLE. FROM PUMP BOTTLE, APPLY ONTO WET HANDS
  • LATHER AND RINSE THOROUGHLY
Label Copy

Active Ingredient

BENZALKONIUM CHLORIDE 0.13%

Other Information

STORE AT ROOM TEMPERATURE

Inactive Ingredients

WATER (AQUA), CETRIMONIUM CHLORIDE, GLYCERIN, LAURYL/MYRISTYL AMIDOPROPYL AMINE OXIDE, COCAMIDE MEA, SODIUM CHLORIDE, PEG-120 METHYL GLUCOSE DIOLEATE, FRAGRANCE (PARFUM), CITRIC ACID, TETRASODIUM EDTA, SODIUM SULFATE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, RED 40 (CI 16035), YELLOW 5 (CI 19140), RED 33 (CI 17200)

When Using This Product
  • AVOID CONTACT WITH EYES
  • IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER
Stop Use and Ask A Doctor If

IRRITATION OR REDNESS DEVELOPS AND LASTS

Keep Out of Reach of Children

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

Structured Label Content

Uses (USES)

HELPS ELIMINATE BACTERIA ON HANDS

Purpose (PURPOSE)

ANTIBACTERIAL

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY

Directions (DIRECTIONS)
  • USE AS A REFILL FOR A PUMP DISPENSING BOTTLE. FROM PUMP BOTTLE, APPLY ONTO WET HANDS
  • LATHER AND RINSE THOROUGHLY
Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

BENZALKONIUM CHLORIDE 0.13%

Other Information (OTHER INFORMATION)

STORE AT ROOM TEMPERATURE

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER (AQUA), CETRIMONIUM CHLORIDE, GLYCERIN, LAURYL/MYRISTYL AMIDOPROPYL AMINE OXIDE, COCAMIDE MEA, SODIUM CHLORIDE, PEG-120 METHYL GLUCOSE DIOLEATE, FRAGRANCE (PARFUM), CITRIC ACID, TETRASODIUM EDTA, SODIUM SULFATE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, RED 40 (CI 16035), YELLOW 5 (CI 19140), RED 33 (CI 17200)

When Using This Product (WHEN USING THIS PRODUCT)
  • AVOID CONTACT WITH EYES
  • IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER
Stop Use and Ask A Doctor If (STOP USE AND ASK A DOCTOR IF)

IRRITATION OR REDNESS DEVELOPS AND LASTS

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:57.404572 · Updated: 2026-03-14T22:54:02.195419