Cetylpyridinium chloride

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

# Overview
Cetylpyridinium chloride is a antiseptic that is FDA approved for the treatment of gingivitis.   Common adverse reactions include staining of the teeth and tongue.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)

### Indications
- helps control plaque that leads to gingivitis

### Dosage

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Cetylpyridinium chloride in adult patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Cetylpyridinium chloride in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)

### Indications
- helps control plaque that leads to gingivitis

### Dosage

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Cetylpyridinium chloride in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Cetylpyridinium chloride in pediatric patients.

# Contraindications
There is limited information regarding Cetylpyridinium chloride Contraindications in the drug label.

# Warnings
- Keep out of reach of children under 6 years of age.
- If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
- Stop use and ask a dentist if
- gingivitis, bleeding, or redness persists for more than 2 weeks
- you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth
- These may be signs or symptoms of periodontitis, a serious form of gum disease.

# Adverse Reactions

## Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Cetylpyridinium chloride in the drug label.

## Postmarketing Experience
staining of the teeth and tongue

# Drug Interactions
There is limited information regarding Cetylpyridinium chloride Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA):
- Pregnancy Category
Pregnancy Category (AUS):
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Cetylpyridinium chloride in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Cetylpyridinium chloride during labor and delivery.

### Nursing Mothers
There is no FDA guidance on the use of Cetylpyridinium chloride with respect to nursing mothers.

### Pediatric Use
There is no FDA guidance on the use of Cetylpyridinium chloride with respect to pediatric patients.

### Geriatic Use
There is no FDA guidance on the use of Cetylpyridinium chloride with respect to geriatric patients.

### Gender
There is no FDA guidance on the use of Cetylpyridinium chloride with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Cetylpyridinium chloride with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Cetylpyridinium chloride in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Cetylpyridinium chloride in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Cetylpyridinium chloride in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Cetylpyridinium chloride in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Oral

### Monitoring
There is limited information regarding Monitoring of Cetylpyridinium chloride in the drug label.

# IV Compatibility
There is limited information regarding IV Compatibility of Cetylpyridinium chloride in the drug label.

# Overdosage
There is limited information regarding Overdose of Cetylpyridinium chloride in the drug label.

# Pharmacology

## Mechanism of Action
There is limited information regarding Cetylpyridinium chloride Mechanism of Action in the drug label.

## Structure
- ACTIVE INGREDIENT (IN EACH 20 ML)
- cetylpyridinium chloride (0.05% w/w)
- INACTIVE INGREDIENTS
- water, glycerin, propylene glycol, sorbitol, polysorbate 20, sodium benzoate, flavor, phosphoric acid, menthol, sodium saccharin, FD&C blue no. 1

## Pharmacodynamics
There is limited information regarding Pharmacodynamics of Cetylpyridinium chloride in the drug label.

## Pharmacokinetics
There is limited information regarding Pharmacokinetics of Cetylpyridinium chloride in the drug label.

## Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Cetylpyridinium chloride in the drug label.

# Clinical Studies
There is limited information regarding Clinical Studies of Cetylpyridinium chloride in the drug label.

# How Supplied
There is limited information regarding Cetylpyridinium chloride How Supplied in the drug label.

## Storage
- store at controlled room temperature 20-25 C (68-77 F)
- this rinse is not intended to replace brushing or flossing

# Images

## Drug Images

## Package and Label Display Panel

### PRINCIPAL DISPLAY PANEL - 30 ML BOTTLE LABEL

### Ingredients and Appearance

# Patient Counseling Information
- QUESTIONS OR COMMENTS?
- Call toll-free 1-800-468-6502

# Precautions with Alcohol
- Alcohol-Cetylpyridinium chloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- COLGATE TOTAL PEPPERMINT

# Look-Alike Drug Names
There is limited information regarding the look alike drug names

# Drug Shortage Status

# Price