drug facts

drug facts
SPL v1
SPL
SPL Set ID eb5938de-5ccf-4c68-8315-7cca38b0687c
Route
topical
Published
Effective Date 2016-08-22
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 aloe vera leaf green tea leaf polyquaternium-7 (70/30 acrylamide/dadmac; 1600000 mw) xanthan gum edetate sodium polysorbate 20 sodium citrate propylene glycol citric acid monohydrate methylchloroisothiazolinone methylisothiazolinone fd&c blue no. 1 ext. d&c violet no. 2

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2016-08-18

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%


Medication Information

Warnings

For external use only.

Uses

helps eliminate bacterial on hands.

Purpose

Antibacterial

Directions

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

Other Information

Store at room temperature.

Inactive Ingredients

Water (Aqua), Cocamidopropyl Betaine, Glycerin, Decyl Glucoside, Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Fragrance (Parfum), Polyquaternium-7, Xanthan Gum, Tetrasodium EDTA, Polysorbate 20, Sodium Citrate, Propylene Glycol, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, Blue1 (CI 42090), Ext. Violet 2 (CI 60730).

Description

Benzalkonium Chloride 0.13%

Label Copy

Active Ingredient

Benzalkonium Chloride 0.13%

Questions Or Comments?

1-248-449-9300

When Using This Product

avoid contact with eyes. If contact occurs, 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 help or contact a Poison Control Center immediately.


Structured Label Content

Warnings

For external use only.

Uses

helps eliminate bacterial on hands.

Purpose

Antibacterial

Directions

Pump onto dry 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, Glycerin, Decyl Glucoside, Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Fragrance (Parfum), Polyquaternium-7, Xanthan Gum, Tetrasodium EDTA, Polysorbate 20, Sodium Citrate, Propylene Glycol, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, Blue1 (CI 42090), Ext. Violet 2 (CI 60730).

Label Copy

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

Questions Or Comments? (Questions or comments?)

1-248-449-9300

When Using This Product (When using this product)

avoid contact with eyes. If contact occurs, 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 help or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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