Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 3e3f9582-4915-4020-88f2-ccf68661598c
Route
TOPICAL
Published
Effective Date 2017-06-07
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 Red No. 4 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-06-06

Description

Benzalkonium Chloride 0.13%

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Uses
  • For washing to decrease bacteria on the skin.
Warnings

For external use only.

Directions
  • Pumpm onto dry hands, work into a lther. Rinse thoroughly.
Label Copy

Active Ingredient

Benzalkonium Chloride 0.13%

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 4 (CI 14700), Yellow 5 (CI 19140).

Questions? Comments?

1-866-322-2439

When Using This Product
  • avoid contat with eyes. If contact occurs, rinse 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 develops and lasts.

Structured Label Content

Uses
  • For washing to decrease bacteria on the skin.
Purpose

Antibacterial

Warnings

For external use only.

Directions
  • Pumpm onto dry hands, work into a lther. Rinse thoroughly.
Label Copy

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

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 4 (CI 14700), Yellow 5 (CI 19140).

Questions? Comments?

1-866-322-2439

When Using This Product (When using this product)
  • avoid contat with eyes. If contact occurs, rinse 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 develops and lasts.

Advanced Ingredient Data


Raw Label Data

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