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SmileGuard Orthodontic Brace Relief

Dosage form: rinse
Ingredients: SODIUM FLUORIDE 0.05mL in 100mL
Labeler: Dr. Fresh, Inc.
NDC Code: 64893-600

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

SmileGuard Orthodontic Brace Relief Rinse

Active Ingredient

Sodium Fluoride   0.05 percent

(0.02 percent w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities.

Warnings

Keep out of reach of children.

If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.

Directions

Adults and children 6 years of age and older:

  • use once a day after  brushing your teeth with a toothpaste
  • remove cap
  • pour 10 milliters (10 mL mark on inside of cap); do not fill above 10 mL mark
  • vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing
  • instruct children under 12 years of age in good rinsing habits ( to minimize swallowing)
  • supervise children as necessary until capable of using without supervision
Children under 6 years of age: consult a dentist or doctor

Inactive Ingredients Aloe Vera Juice, Citric Acid, Flavor, Glycerin, Poloxamer 407, Purified Water, Sodium Benzoate, Sodium Hexametaphosphate, Xylitol,  Zinc Lactate

Other Information
  • Store at room temperature

SmileGuard and related trademarks, names, logos and patents are the property of Dr. Fresh, Inc and are registered and/or used in the U.S. and countries around the world. 2010 Dr. Fresh, Inc. Several Design and Utility Patents granted or pending worldwide.


Questions? Comments?

Toll Free: 1-866-DRFRESH visit us online at: www.drfresh.com USA- Dr. Fresh Inc. Buena Park, CA 90620 USA

U.K- Grosvenor Consumer Products Limited

25 Gore RoadAB

Canada- Dr. Fresh Inc,

Ontario, Canada L7C2T4

Bunrham Bucks SL1,

Enter section text here

SMILEGUARD ORTHODONTIC BRACE RELIEF 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64893-600
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE0.05 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
CITRIC ACID MONOHYDRATE 
GLYCERIN 
POLOXAMER 407 
WATER 
SODIUM BENZOATE 
SODIUM POLYMETAPHOSPHATE 
XYLITOL 
ZINC LACTATE 
Packaging
#Item CodePackage Description
1NDC:64893-600-0044 mL in 1 BOTTLE
2NDC:64893-600-01473 mL in 1 BOTTLE
3NDC:64893-600-02237 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/27/2010
Labeler - Dr. Fresh, Inc. (033059119)
Establishment
NameAddressID/FEIOperations
Dr. Fresh, Inc.033059119manufacture

Revised: 10/2010
Document Id: e2eaf50f-5972-4a9a-bc6a-fcc0fe0a0110
Set id: 8e93e405-c85b-49e7-81ac-779aa9483556
Version: 3
Effective Time: 20101027
 
Dr. Fresh, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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