UltraCare Alcohol Free

Drug Labeling and Warnings

Drug Details [pdf]

ULTRACARE ALCOHOL FREE FRESH MINT- sodium fluoride mouthwash 
Ranir LLC

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.

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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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66923-235
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SUCRALOSE (UNII: 96K6UQ3ZD4)
EUCALYPTOL (UNII: RV6J6604TK)
SODIUM BENZOATE (UNII: OJ245FE5EU)
THYMOL (UNII: 3J50XA376E)
METHYL SALICYLATE (UNII: LAV5U5022Y)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66923-235-15	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/31/2015	12/31/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	07/31/2015	12/31/2018

Labeler - Ranir LLC (364567615)

Revised: 11/2019

Document Id: 969f40de-08cc-535c-e053-2995a90aacc4

34390-5

Set id: 3ae3d27b-9216-4091-880b-92598840fad1

Version: 2

Effective Time: 20191105