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SmileGuard Just 4 Me

Dosage form: paste
Ingredients: SODIUM FLUORIDE 0.15g in 100g
Labeler: Dr. Fresh, Inc.
NDC Code: 64893-800

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 Just 4 Me Kit

Active Ingredient

Sodium fluoride 0.243% (0.15% w/v fluoride ion)

Purpose

Anti-cavity toothpaste

Uses

Helps prevent against cavities

Warnings

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately

Keep out of the reach of children under 6 years of age.

Directions
  • Adults and children 2 years and older: Brush teeth thoroughly after meals or at least twice a day  as directed by a dentist or physician.
  • Do not swallow
  • To minimize swallowing, use a pea-sized amount for children under 6
  • Supervise children's brushing until good habits are established.
  • Children under 2 years: Ask a dentist

Inactive Ingredients

Sorbitol, Water, Hydrated Silica, Trisodium Phosphate, Sodium Lauryl Sulfate, Sodium Phosphate, Xanthan Gum, Flavor, Sodium Saccharin, Carbomer 956, Mica, Titanium Dioxide, Blue 1

Questions? 

1-800-492-7378; www.crest.com



SMILEGUARD JUST 4 ME 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64893-800
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
WATER 
HYDRATED SILICA 
PHOSPHATE ION 
SODIUM LAURYL SULFATE 
SODIUM PHOSPHATE 
XANTHAN GUM 
SACCHARIN SODIUM 
MICA 
TITANIUM DIOXIDE 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:64893-800-011 TUBE in 1 POUCH
124 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/17/2011
Labeler - Dr. Fresh, Inc. (078508990)
Establishment
NameAddressID/FEIOperations
The Procter & Gamble Manufacturing Company007130032manufacture(64893-800)

 
Dr. Fresh, Inc.

Medically reviewed on Jul 24, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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