Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 64a13de7-25ac-40b8-9c89-0c51668db76d
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 Polysorbate 20 Glycerin Sodium Citrate Xanthan Gum Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Decyl Glucoside Edetate Sodium Citric Acid Monohydrate Green Tea Leaf Aloe Vera Leaf Methylchloroisothiazolinone Methylisothiazolinone Fd&c Red No. 4 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-08-18

Description

Benzalkonium Chloride 0.13%

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Uses

for hand washing to decrease bacteria on the skin.

Warnings

For external use only.

Directions
  • apply onto dry hands.
  • 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, Glycerin, Fragrance (Parfum), Sodium Citrate, Xanthan Gum, Polyquaternium-7, Decyl Glucoside, Tetrasodium EDTA, Citric Acid, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Juice, Methylchloroisothiazolinone, Methylisothiazolinone, Red 4 (CI 14700), Yellow 5 (CI 19140).

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 develop and last.

Keep Out of Reach of Children.

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


Structured Label Content

Uses

for hand washing to decrease bacteria on the skin.

Purpose

Antibacterial

Warnings

For external use only.

Directions
  • apply onto dry hands.
  • 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, Glycerin, Fragrance (Parfum), Sodium Citrate, Xanthan Gum, Polyquaternium-7, Decyl Glucoside, Tetrasodium EDTA, Citric Acid, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Juice, Methylchloroisothiazolinone, Methylisothiazolinone, Red 4 (CI 14700), Yellow 5 (CI 19140).

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 develop and last.

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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