Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 0a244d46-8a31-48ad-aa41-a8690676c659
Route
TOPICAL
Published
Effective Date 2016-10-31
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 Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-10-27

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 to refill a pump bottle. From the pump bottle, apply a small amount to hands. Lather into a rich foam and rinse clean.

Label Copy

Active Ingredient

Benzalkonium chloride 0.13%

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 (Parfum0, Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Yellow 5 (CI 19140).

When Using the Product

Avoid contact with eyes. In case of contact, rinse 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 hlep or contact a Poison Control Center immediately.


Structured Label Content

Uses

Helps eliminate bacteria on hands

Purpose

Antibacterial

Warnings

For external use only

Directions

Use to refill a pump bottle. From the pump bottle, apply a small amount to hands. Lather into a rich foam and rinse clean.

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, Lauramidopropylamine Oxide, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum0, Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Yellow 5 (CI 19140).

When Using the Product (When using the product)

Avoid contact with eyes. In case of contact, rinse 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 hlep or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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