Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID b4a7e0b7-47d4-4ed0-a1c5-6c3e9dce3fa2
Route
TOPICAL
Published
Effective Date 2017-05-01
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 Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Xanthan Gum Edetate Sodium Sodium Citrate Citric Acid Monohydrate Methylchloroisothiazolinone Methylisothiazolinone D&c Yellow No. 10 Fd&c Green No. 3

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-04-28

Description

Benzalkonium Chloride 0.13%

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Uses

helps eliminate bacteria on the skin.

Warnings

For external use only.

Directions

Use only to refill a foaming hand soap pump bottle. From pump bottle, apply onto dry hands work into a lather and rinse thoroughly.

Label Copy

Active Ingredient

Benzalkonium Chloride 0.13%

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, Polyquaternium-7, Xanthan Gum, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 10 (CI 47005), Green 3 (CI 42053).

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 ingestion, get medical help or contact a Poison Control Cneter immediately.

Stop Using This Product and Ask A Doctor If

irritation or redness develops and lasts.


Structured Label Content

Uses

helps eliminate bacteria on the skin.

Purpose

Antibacterial

Warnings

For external use only.

Directions

Use only to refill a foaming hand soap pump bottle. From pump bottle, apply onto dry hands work into a lather and rinse thoroughly.

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, Polysorbate 20, Fragrance (Parfum), Glycerin, Decyl Glucoside, Hydroxyethylcellulose, Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Polyquaternium-7, Xanthan Gum, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 10 (CI 47005), Green 3 (CI 42053).

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 ingestion, get medical help or contact a Poison Control Cneter immediately.

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

irritation or redness develops and lasts.


Advanced Ingredient Data


Raw Label Data

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