Pro-Den Rx

Name: Pro-Den Rx

Description

Pro-DenRx® Neutral Sodium Fluoride Rinse is a neutral, aqueous solution.

Contraindications

Do not use in children under age 6 years unless recommended by a dentist or physician.

Warnings

PLEASE KEEP OUT OF REACH OF CHILDREN. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away. READ DIRECTIONS CAREFULLY BEFORE USING.

Overdosage

Swallowing a normal treatment dose (approximately 9 mg. of fluoride) is not harmful.

Package label.principal display panel

Pro-Den Rx 
sodium fluoride rinse
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59883-920
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Fluoride (Fluoride Ion) Fluoride Ion 0.9 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water  
Cetylpyridinium Chloride  
Citric Acid Monohydrate  
Potassium Sorbate  
Sucralose  
Sodium Hydroxide  
Product Characteristics
Color      Score     
Shape Size
Flavor MINT (MINT) Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:59883-920-16 473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/21/2008
Pro-Den Rx 
sodium fluoride rinse
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59883-922
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Fluoride (Fluoride Ion) Fluoride Ion 0.9 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water  
Cetylpyridinium Chloride  
Citric Acid Monohydrate  
Potassium Sorbate  
Sucralose  
Sodium Hydroxide  
Product Characteristics
Color      Score     
Shape Size
Flavor BERRY (BERRY) Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:59883-922-16 473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/21/2008 12/31/2014
Labeler - Den-mat Holdings, Llc (809857704)
Revised: 12/2015   Den-mat Holdings, Llc

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very upset stomach or throwing up.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to fluoride topical: mucous membrane powder for reconstitution, mucous membrane solution, topical cream, topical gel, topical kit, topical paste, topical solution, topical swab

Hypersensitivity

Hypersensitivity side effects including allergic reactions have been reported.[Ref]

Oncologic

It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and animal cells at doses much higher than those to which humans are exposed. In vivo data are conflicting.[Ref]

Some side effects of Pro-Den Rx may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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