Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID c421c473-d1b7-4ba5-a562-1c29f64e9b43
Route
TOPICAL
Published
Effective Date 2022-04-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetylpyridinium (11.18 mL)
Inactive Ingredients
Water Hydrogenated Castor Oil Menthol, (+)- Sucralose

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-15

Description

Cetylpyridinium chloride 0.09%

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

Description

Cetylpyridinium chloride 0.09%

Uses

Helps fight odor causing bacteria

Warnings

For external use only:

Do not use this product if gums are irritated or bleeding unless directed to do by a doctor or dentist. If more than twice the recommended amount for tongue spraying is accidentally swallowed, get medical help or contact a Poison Control Center immediately. Do not spray into the eyes. Do not spray into the eyes. If spray gets into the eyes, hold eyelids apart and flush the eye continuously with running water for at least 15 minutes.

Directions

Adults and children 12 years of age and older: Spray 3 times in the oral cavity. Children 6-12 years of age: Supervise use. Children under 6 years: Do not use.

Active Ingredient

Cetylpyridinium chloride 0.09%

Inactive Ingredients

Citric Acid, Flavor, Glycerin, Menthol, PEG-40 Hydrogenated Castor Oil, Potassium Sorbate, Sodium Benzoate, Sucralose, Water.

Keep Out of Reach of Children

If swallowed get medical help or contact a Poison Control Center right away.

Package/label Principal Display Panel

Structured Label Content

Uses

Helps fight odor causing bacteria

Purpose

Antibacterial

Warnings

For external use only:

Do not use this product if gums are irritated or bleeding unless directed to do by a doctor or dentist. If more than twice the recommended amount for tongue spraying is accidentally swallowed, get medical help or contact a Poison Control Center immediately. Do not spray into the eyes. Do not spray into the eyes. If spray gets into the eyes, hold eyelids apart and flush the eye continuously with running water for at least 15 minutes.

Directions

Adults and children 12 years of age and older: Spray 3 times in the oral cavity. Children 6-12 years of age: Supervise use. Children under 6 years: Do not use.

Active Ingredient (Active ingredient)

Cetylpyridinium chloride 0.09%

Inactive Ingredients

Citric Acid, Flavor, Glycerin, Menthol, PEG-40 Hydrogenated Castor Oil, Potassium Sorbate, Sodium Benzoate, Sucralose, Water.

Keep Out of Reach of Children

If swallowed get medical help or contact a Poison Control Center right away.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Advanced Ingredient Data


Raw Label Data

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