Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID e474f6f3-01a1-499a-b028-5442fbbb455f
Route
TOPICAL
Published
Effective Date 2017-05-10
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 2017-05-09

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

use only to refill a foaming hand soap pump bottle. Pump onto dry hands. Work into a rich foamy lather, rinse thoroughly and dry.

Label Copy

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

store at room temperature

Inactive Ingredients

Water (Aqua), Cocamidopropyl Betaine, Glyceri, 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, Blue 1 (CI 42090), Ext. Violet 2 (CI 60730).

When Using This Product

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

Keep Out of Reach of Children.

In case of accidental ingeation, get medical help or contact a Poison Control Center immediately

Stop Using This Product and Ask A Doctor If

irritation and redness develops and lasts.


Structured Label Content

Uses

helps eliminate bacteria on hands.

Purpose

Antibacterial

Warnings

For external use only.

Directions

use only to refill a foaming hand soap pump bottle. Pump onto dry hands. Work into a rich foamy lather, rinse thoroughly and dry.

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, Glyceri, 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, Blue 1 (CI 42090), Ext. Violet 2 (CI 60730).

When Using This Product (When using this product)

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

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental ingeation, get medical help or contact a Poison Control Center immediately

Stop Using This Product and Ask A Doctor If (Stop using this product and ask a doctor if)

irritation and redness develops and lasts.


Advanced Ingredient Data


Raw Label Data

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