Fidelis APG Gel

Name: Fidelis APG Gel

Indications and Usage

  • A stable thixotropic fluoride treatment gel used to help prevent dental decay.
  • For Professional Use Only. This product is not intended for home or unsupervised consumer use.

Warnings

  • Keep out of reach of children.
  • Do not swallow. If product is accidentally swallowed in quantities greater than would normally occur with a treatment gel, seek medical help or contact a Poison Control Center right away.
  • Read directions carefully before using.

Inactive Ingredients

Citric Acid, FD&C Red #40, FD&C Yellow #5 (tartrazine) as a color additive, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol.

FIDELIS APF 
sodium fluoride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69962-019
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 5.6 g  in 454 g
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE  
FD&C RED NO. 40  
FD&C YELLOW NO. 5  
Magnesium Aluminum Silicate  
Phosphoric Acid  
Polysorbate 20  
Sodium Benzoate  
SACCHARIN SODIUM  
TITANIUM DIOXIDE  
WATER  
XANTHAN GUM  
XYLITOL  
Product Characteristics
Color orange Score     
Shape Size
Flavor ORANGE, VANILLA Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:69962-019-15 454 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/01/2014
Labeler - Webco Dental & Medical Supplies, Inc. (013554608)
Revised: 07/2015   Webco Dental & Medical Supplies, Inc.

For the Consumer

Applies to fluoride topical: dental cream, dental gel, dental paste, mouth/throat concentrate, mouth/throat liquid, mouth/throat paste, mouth/throat solution

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 Fidelis APG Gel 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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