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Top Care Enamel Guard

Medically reviewed on Nov 30, 2017

Dosage form: paste, dentifrice
Ingredients: SODIUM FLUORIDE 1.5g in 1g, POTASSIUM NITRATE 5.0g in 1g
Labeler: TOPCO Assoc. LLC
NDC Code: 36800-186

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.

Drug Facts

Active ingredients / Purpose

Potassium nitrate 5%....................................................Antihypersensitivity

Sodium fluoride 0.15% w/v fluoride ion.........................Anticavity

Uses
  • aids in reducing sensitivity
  • aids in the prevention of dental cavities

When using this product do not use longer than 4 weeks unless recommended by a dentist or physician. See your dentist if the problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physican. Make sure to brush all sensitive areas of the teeth. Do not swallow.

Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Children under 12 years of age: consult a dentist or a doctor.

Other Information

Store in a cool dry place. Keep tube capped when not in use.

Inactive ingredients

cocamidopropyl betaine, flavor, glycerin, hydrated silica, PEG-8, sodium hydroxide, sodium saccharin, sorbitol, titanium dioxide, water, xanthan gum

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TOP CARE  ENAMEL GUARD
fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-186
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.5 g  in 1 g
POTASSIUM NITRATE (NITRATE ION) POTASSIUM NITRATE5.0 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
SACCHARIN SODIUM 
SORBITOL 
POLYETHYLENE GLYCOL 400 
TITANIUM DIOXIDE 
SODIUM HYDROXIDE 
GLYCERIN 
XANTHAN GUM 
HYDRATED SILICA 
COCAMIDOPROPYL BETAINE 
SODIUM METHYL COCOYL TAURATE 
Product Characteristics
Colorwhite (white to light tan) Score    
ShapeSize
FlavorMINT (mint) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:36800-186-691 TUBE (TUBE) in 1 CARTON
1NDC:36800-186-62113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/20/2011
Labeler - TOPCO Assoc. LLC (006935977)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIOperations
Lornamead126440440manufacture(36800-186), pack(36800-186)

 
TOPCO Assoc. LLC

Further information

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

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