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UltraCare Alcohol Free Fresh Mint

Medically reviewed on August 28, 2017

Dosage form: mouthwash
Ingredients: SODIUM FLUORIDE 0.1mg in 1mL
Labeler: Ranir LLC
NDC Code: 66923-235

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.

UltraCare Alcohol Free

Drug Facts

Active ingredient

Sodium fluoride 0.02% (0.01% 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, get medical help or contact a Poison Control Center right away.

Directions
  • Adults and children 6 years of age and older:
    •    Use twice a day after brushing your teeth with a toothpaste.
    •    Vigorously swish 10 mL (2 teaspoonfuls) 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.
  • Close cap fully after use, until the cap is felt to “click”, to reengage the child resistant cap. 

Other Information

Store at room temperature. Cold temperature may temporarily cloud this product.

Inactive ingredients

water, sorbitol, propylene glycol, poloxamer 407, phosphoric acid, sodium lauryl sulfate, sodium saccharin, disodium phosphate, sucralose, eucalyptol, sodium benzoate, thymol, methyl salicylate, flavor, menthol, red 40, blue 1

Distributed by
Demoulas Supermarkets, Inc.
Tewksbury, MA 01876

Made in Canada

PRINCIPAL DISPLAY PANEL

UltraCare Alcohol Free

Anticavity Fluoride Mouthwash   

6 Benefits

• Restores Enamel

• Helps Prevent Cavities

• Kills Bad Breath Germs

• Strengthens Teeth

• Freshens Breath

• Cleans the Whole Mouth

IMPORTANT: Read directions for proper use  

1 L (33.8 FL OZ)

ULTRACARE ALCOHOL FREE  FRESH MINT
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66923-235
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
PROPYLENE GLYCOL 
POLOXAMER 407 
PHOSPHORIC ACID 
SODIUM LAURYL SULFATE 
SACCHARIN SODIUM 
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 
SUCRALOSE 
EUCALYPTOL 
SODIUM BENZOATE 
THYMOL 
METHYL SALICYLATE 
MENTHOL, UNSPECIFIED FORM 
FD&C RED NO. 40 
FD&C BLUE NO. 1 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:66923-235-151000 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35507/31/2015
Labeler - Ranir LLC (364567615)

 
Ranir LLC

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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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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