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

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

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.

Description

Benzalkonium Chloride 0.13%

Label Copy

Active Ingredient

Benzalkonium Chloride 0.13%

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

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)

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.

Label Copy

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

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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