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

Purpose

Antibacterial

Description

Benzalkonium chloride 0.13%


Medication Information

Warnings

For external use only

Uses

Helps eliminate bacteria on hands.

Purpose

Antibacterial

Directions
  • Apply onto dry hands.
  • Lather and rinse thoroughly.
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).

Description

Benzalkonium chloride 0.13%

Label Copy

Active Ingredient

Benzalkonium chloride 0.13%

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

Warnings

For external use only

Uses

Helps eliminate bacteria on hands.

Purpose

Antibacterial

Directions
  • Apply onto dry hands.
  • Lather and rinse thoroughly.
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).

Label Copy

Active Ingredient (Active ingredient)

Benzalkonium chloride 0.13%

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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