drug facts

drug facts
SPL v1
SPL
SPL Set ID cf882d67-74d5-4ec2-b707-b501cc699a9f
Route
topical
Published
Effective Date 2017-04-12
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 sodium chloride coco monoethanolamide 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 2017-04-11

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%


Medication Information

Warnings

For external use only.

Uses

helps eliminate bacteria on hands.

Purpose

Antibacterial

Directions
  • apply onto wet hands
  • lather and rinse thoroughly
Other Information

store at room temperature

Inactive Ingredients

Water (Aqua), Cetrimonium Chloride, Glycerin, Lauramidopropylamine Oxide, Sodium Chloride, Cocamide MEA, 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).

Description

Benzalkonium Chloride 0.13%

Label Copy

Active Ingredient

Benzalkonium Chloride 0.13%

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

Warnings

For external use only.

Uses

helps eliminate bacteria on hands.

Purpose

Antibacterial

Directions
  • apply onto wet hands
  • lather and rinse thoroughly
Other Information (Other information)

store at room temperature

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Cetrimonium Chloride, Glycerin, Lauramidopropylamine Oxide, Sodium Chloride, Cocamide MEA, 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).

Label Copy

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

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

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