Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 5b34aa4c-725c-4756-e053-2a91aa0a27d9
Route
TOPICAL
Published
Effective Date 2017-10-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.1 g)
Inactive Ingredients
Water Propylene Glycol Cocamidopropyl Betaine Benzyl Alcohol Methylchloroisothiazolinone Methylisothiazolinone Edetate Sodium Cetrimonium Chloride Citric Acid Monohydrate Aloe Vera Leaf Alpha-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-06-06

Description

Benzalkonium Chloride 0.1%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Benzalkonium Chloride 0.1%

Uses

•decreases bacteria on the skin

Stop Use

Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours

Warnings

•For external use only

Directions

• for adults and children 2 years and over use on hands and face to clean and refresh, allow skin to air dry. For children under 2 years of age ask a doctor before use.

Do Not Use

•Over large areas of the body if you are allergic to any of the ingredients

Package Label

Active Ingredient

Benzalkonium Chloride 0.1%

Inactive Ingredients

water, propylene glycol, cocamidopropyl betaine, peg-7 glyceryl cocoate, fragrance, benzyl alcohol, methylchloroisothiazolinine, methylisothiazolinone, tetrasodium EDTA, peg-40 hydrogenated castor oil, cetrimonium chloride, citric acid, aloe vera extract, alphatocopherol acetate

When Using This Product



•do not get into eyes. •If contact occurs, rinse thoroughly with water.

Keep Out of Reach of Children

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

•decreases bacteria on the skin

Purpose

Antiseptic

Stop Use (Stop use)

Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours

Warnings

•For external use only

Directions

• for adults and children 2 years and over use on hands and face to clean and refresh, allow skin to air dry. For children under 2 years of age ask a doctor before use.

Do Not Use (Do not use)

•Over large areas of the body if you are allergic to any of the ingredients

Package Label

Active Ingredient

Benzalkonium Chloride 0.1%

Inactive Ingredients

water, propylene glycol, cocamidopropyl betaine, peg-7 glyceryl cocoate, fragrance, benzyl alcohol, methylchloroisothiazolinine, methylisothiazolinone, tetrasodium EDTA, peg-40 hydrogenated castor oil, cetrimonium chloride, citric acid, aloe vera extract, alphatocopherol acetate

When Using This Product (When using this product)



•do not get into eyes. •If contact occurs, rinse thoroughly with water.

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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