Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 70fa6d80-c7c2-4666-8cff-55c43fa169a9
Route
TOPICAL
Published
Effective Date 2013-09-23
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 2013-09-19

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/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).

Questions Or Comments?

1-800-289-8343

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/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).

Questions Or Comments? (QUESTIONS OR COMMENTS?)

1-800-289-8343

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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