Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 6920a18d-73f7-aeb8-e053-2991aa0ad79e
Route
TOPICAL
Published
Effective Date 2018-04-05
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 Peg-7 Glyceryl Cocoate Methylchloroisothiazolinone Methylisothiazolinone Edetate Sodium Cetrimonium Chloride Citric Acid Monohydrate Benzyl Alcohol Alpha-tocopherol Acetate Polyoxyl 40 Hydrogenated Castor Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-04-02

Description

Benzalkonium Chloride 0.1%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Benzalkonium Chloride 0.1%

Uses

decreases bacteria on the skin

Warnings

For external use only

Directions

adults and children 2 years and over ■ apply to hands

■ allow to dry without wiping.

children under 2 years ask a doctor before use.

Do Not Use

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, PEG-40 hydrogenated castor oil, tetrasodium EDTA, cetrimonium chloride, citric acid, tocopherol acetate

When Using This Product



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

Stop Use and Ask A Doctor If

irritation or rash develops and continues for more than 72 hours

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

Warnings

For external use only

Directions

adults and children 2 years and over ■ apply to hands

■ allow to dry without wiping.

children under 2 years ask a doctor before use.

Do Not Use (Do not use)

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, PEG-40 hydrogenated castor oil, tetrasodium EDTA, cetrimonium chloride, citric acid, tocopherol acetate

When Using This Product (When using this product)



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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

irritation or rash develops and continues for more than 72 hours

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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