PCXX Foam

Name: PCXX Foam

Directions For Use

DIRECTIONS FOR USE:

1. Use after prophylaxis.

2. Shake bottle vigorously for 3-4 seconds.

3. For adults and children age 6 and older.

4. Invert applicator.

5. Place nozzle to applicator tray and dispense.

6. Allow foam to expand in tray.

7. Have patient bite down for up to 4 minutes.

8. Remove trays and have patient expectorate excess.

9. Do not eat or drink for 30 minutes after use.

Product Label

PCxx

Professional Care Products

NEUTRAL FOAM

TOPICAL FLUORIDE FOAM

2.0% Sodium Fluoride

NO FLAVOR

Net Contents: 125 g

NPN# 800004635

NDC# 062007-105-07

Ross Healthcare Inc.  1-800-663-8303 / www.rosshealthcare.org

Made in Canada

LOT 27121A6

EXPIRY 12-2014

PCXX 
sodium fluoride aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:62007-105
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 2.5 g  in 125 g
Inactive Ingredients
Ingredient Name Strength
GLYCERIN  
XYLITOL  
SUCRALOSE  
POLOXAMER 407  
SODIUM LAURYL SULFATE  
XANTHAN GUM  
POTASSIUM SORBATE  
Packaging
# Item Code Package Description
1 NDC:62007-105-07 125 g in 1 CANISTER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 12/12/2012
Labeler - Ross Healthcare Inc. (244249012)
Registrant - Ross Healthcare Inc. (244249012)
Establishment
Name Address ID/FEI Operations
Ross Healthcare Inc. 244249012 manufacture(62007-105)
Revised: 12/2012   Ross Healthcare 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

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.

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 PCXX Foam 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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