Drug Label

Drug
SPL v1
SPL
SPL Set ID 35fda3c0-98cf-467b-8ffd-9dac5db12a53
Route
TOPICAL
Published
Effective Date 2015-03-20
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 2015-03-19

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

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/MYRSTYL 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)

Questions Or Comments?

1-800-925-4733

When Using This Product

AVOID CONTACT WITH EYES. IN CASE OF CONTACT, RINSE 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)

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/MYRSTYL 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)

Questions Or Comments? (QUESTIONS OR COMMENTS?)

1-800-925-4733

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES. IN CASE OF CONTACT, RINSE 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

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