drug facts

drug facts
SPL v1
SPL
SPL Set ID f07fad0d-3a73-4005-9ddc-5198a0d303e8
Route
topical
Published
Effective Date 2017-06-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (1.3 mg)
Inactive Ingredients
water cocamidopropyl betaine polysorbate 20 glycerin decyl glucoside hydroxyethyl cellulose (5000 cps at 1%) aloe vera leaf green tea leaf propylene glycol polyquaternium-7 (70/30 acrylamide/dadmac; 1600000 mw) edetate sodium sodium citrate citric acid monohydrate sulisobenzone methylchloroisothiazolinone methylisothiazolinone fd&c blue no. 1 ext. d&c violet no. 2

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2017-06-13

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%


Medication Information

Warnings

For external use only.

Uses

Helps eliminate bacteria on hands.

Purpose

Antibacterial

Directions

pump onto hands. Work into a rich foamy lather, rinse thoroughly and dry.

Other Information

store at room temperature.

Inactive Ingredients

Water (Aqua), Cocamidopropyl Betaine, Polysorbate 20, Fragrance (Parfum), Glycerin, Decyl Glucoside, Hydroxyethylcellulose, Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Propylene Glycol, Polyquaternium-7, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Ext. Violet 2 (CI 60730).

Description

Benzalkonium Chloride 0.13%

Label Copy

Active Ingredient

Benzalkonium Chloride 0.13%

When Using This Product

avoid contact with eyes. In case of contact, rinse thoroughly with water.

Stop Use and Ask A Doctor If

irritation and redness develops or 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

pump onto hands. Work into a rich foamy lather, rinse thoroughly and dry.

Other Information (Other information)

store at room temperature.

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Cocamidopropyl Betaine, Polysorbate 20, Fragrance (Parfum), Glycerin, Decyl Glucoside, Hydroxyethylcellulose, Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Propylene Glycol, Polyquaternium-7, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Ext. Violet 2 (CI 60730).

Label Copy

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

When Using This Product (When using this 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 and redness develops or 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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