Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID a61c116f-76e6-4a44-9142-3c57ff925163
Route
TOPICAL
Published
Effective Date 2016-11-04
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 Decyl Glucoside Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Edetate Sodium Coconut Bambusa Vulgaris Leaf Aloe Vera Leaf Methylchloroisothiazolinone Methylisothiazolinone Fd&c Blue No. 1 D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-11-03

Description

Benzalkonium chloride 0.13%

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

Description

Benzalkonium chloride 0.13%

Uses

Helps eliminate bacteria on hands.

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, Decyl Glucoside, Polyquaternium-7, Tetrasodium EDTA, Citric Acid, Cocos Nucifera (Coconut) Fruit Extract, Bambusa Vulgaris Leaf Extract, Aloe Barbadensis Leaf Juice, Methychloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200).

When Using This Product

avoid contact with eyes. In case of contact, rinse thoroughly with water.

Stop Use and Ask A Doctor If

irritation or redness develops 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

Helps eliminate bacteria on hands.

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, Decyl Glucoside, Polyquaternium-7, Tetrasodium EDTA, Citric Acid, Cocos Nucifera (Coconut) Fruit Extract, Bambusa Vulgaris Leaf Extract, Aloe Barbadensis Leaf Juice, Methychloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200).

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 or redness develops 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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