Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID c69f7279-a0b5-4407-a871-1bdb88474e05
Route
TOPICAL
Published
Effective Date 2016-02-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Fd&c Blue No. 1 Green Tea Leaf Cetrimonium Chloride Citric Acid Monohydrate Tangerine Peel Coco Monoethanolamide Glycerin Lauramidopropylamine Oxide Methylchloroisothiazolinone Methylisothiazolinone Peg-120 Methyl Glucose Dioleate Sodium Chloride Sodium Sulfate Edetate Sodium Water Fd&c Yellow No. 5 Ginger

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-02-10

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

Blue 1 (CI 42090), Camellia Sinensis Leaf Extract, Cetrimonium Chloride, Citric Acid, Citrus Nobilis (Mandarin Orange) Peel Extract, Cocamide MEA, Fragrance (Parfum), Glycerin, Lauryl/Myristyl Amidopropyl Amine Oxide, Methylchloroisothiazolinone, Methylisothiazolinone, PEG-120 Methyl Glucose Dioleate, Sodium Chloride, Sodium Sulfate, Tetrasodium EDTA, Water (Aqua), Yellow 5 (CI 19140), Zingiber Offinale (Ginger) Root Extract.

When Using Thhis 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

helps eliminate bacteria on hands

Purpose

Antibacterial

Warnings

For external use only.

Directions
  • apply onto wet hands
  • lather and rinse thoroughly
Label Copy

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

Other Information (Other information)

store at room temperature

Inactive Ingredients (Inactive ingredients)

Blue 1 (CI 42090), Camellia Sinensis Leaf Extract, Cetrimonium Chloride, Citric Acid, Citrus Nobilis (Mandarin Orange) Peel Extract, Cocamide MEA, Fragrance (Parfum), Glycerin, Lauryl/Myristyl Amidopropyl Amine Oxide, Methylchloroisothiazolinone, Methylisothiazolinone, PEG-120 Methyl Glucose Dioleate, Sodium Chloride, Sodium Sulfate, Tetrasodium EDTA, Water (Aqua), Yellow 5 (CI 19140), Zingiber Offinale (Ginger) Root Extract.

When Using Thhis Product (When using thhis 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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