Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 5b6f3180-9c3f-4074-9dd6-e9689ff29d79
Route
TOPICAL
Published
Effective Date 2017-05-24
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 Powdered Cellulose 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 Red No. 4 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-05-23

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
  • use only to refill a refoaming hand soap pump bottle
  • 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, 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, Methyliosthiazolinone, 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 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

Uses

for hand washing to decrease bacteria on the skin.

Purpose

Antibacterial

Warnings

For external use only

Directions
  • use only to refill a refoaming hand soap pump bottle
  • 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, 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, Methyliosthiazolinone, 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 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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