Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 0927b5a2-6f47-4e3b-997a-e7f4ce1df7d9
Route
TOPICAL
Published
Effective Date 2020-03-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Water Cocamidopropyl Betaine Glycerin Decyl Glucoside Hydroxyethyl Cellulose (5000 Cps At 1%) Aloe Vera Leaf Poloxamer 124 Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Edetate Sodium Citric Acid Monohydrate Sodium Citrate Green Tea Leaf Saccharomyces Lysate .alpha.-tocopherol Acetate, Dl- Vitamin A Palmitate Ascorbyl Palmitate Niacinamide Methylchloroisothiazolinone Methylisothiazolinone Fd&c Blue No. 1 D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-16

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

appy 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), Cocamidopropyl Betaine, Glycerin, Decyl Glucoside, Hydroxyethylcellulose, Aloe Barbadensis Leaf Juice, Fragrance (Parfum), Poloxamer 124, Polyquaternium-7, Tetrasodium EDTA, Citric Acid, Sodium Citrate, Camellia Sinensis Leaf Extract, Saccharomyces Ferment, Tocopheryl Acetate, Retinyl Palmitate, Ascorbyl Palmitate, Niacinamide, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200).

Questions Or Comments?

1-800-934-1204

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

helps eliminate bacteria on hands.

Purpose

Antibacterial

Warnings

For external use only.

Directions

appy 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), Cocamidopropyl Betaine, Glycerin, Decyl Glucoside, Hydroxyethylcellulose, Aloe Barbadensis Leaf Juice, Fragrance (Parfum), Poloxamer 124, Polyquaternium-7, Tetrasodium EDTA, Citric Acid, Sodium Citrate, Camellia Sinensis Leaf Extract, Saccharomyces Ferment, Tocopheryl Acetate, Retinyl Palmitate, Ascorbyl Palmitate, Niacinamide, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200).

Questions Or Comments? (Questions or comments?)

1-800-934-1204

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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