Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 536cbfdb-2171-4a27-b1b2-b53c28d0886b
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) Edetate Sodium Sodium Citrate Citric Acid Monohydrate Sulisobenzone Methylchloroisothiazolinone Methylisothiazolinone Fd&c Yellow No. 5 Fd&c Red No. 40 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-04-27

Description

Benzalkonium Chloride 0.13%

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Uses

helps eliminate bacteria on hands.

Section 51945-4

Warnings

For external use only.

Directions

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

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, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40 (CI 47005), Yellow 5 (CI 19140), Blue 1 (CI 42090).

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 Center immediately.

Stop Using This Product and Ask Doctor If

irritation or redness develop and last.


Structured Label Content

Uses

helps eliminate bacteria on hands.

Section 51945-4 (51945-4)

Purpose

Antibacterial

Warnings

For external use only.

Directions

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

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, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40 (CI 47005), Yellow 5 (CI 19140), Blue 1 (CI 42090).

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 Center immediately.

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

irritation or redness develop and last.


Advanced Ingredient Data


Raw Label Data

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