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Orajel Anticavity Fluoride Rinse Alcohol and Sugar Free

Medically reviewed on April 23, 2018

Dosage form: liquid
Ingredients: SODIUM FLUORIDE 0.2mg in 1mL
Labeler: Church & Dwight Co., Inc.
NDC Code: 10237-910

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 ingredient

Sodium Fluoride 0.02%

Purpose

Anticavity

Use aids in the prevention of dental cavities

Warnings

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Keep out of reach of children.

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 teaspoons) of rinse between your teeth for at least 1 minute 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

Other Information do not use if safety seal is broken or missing

Inactive ingredients water, glycerin, sorbitol, poloxamer 407, polysorbate 20, phenylcarbinol, sodium bicarbonate, flavor, sodium benzoate, xylitol, cetylpyridinium chloride, sodium saccharin, blue 1

Questions or comments call us at 1–800–952–5080 M–F 9am–5pm ET or visit our website atwww.orajel.com

Orajel Anticavity Fluoride Rinse

Alcohol & Sugar Free

Orajel

Anticavity Fluoride Rinse

Alcohol & Sugar Free

Fun-tastic Fruit

  • Fights Cavities & Strengthens Enamel
  • Cleans Where Brushing May Miss
  • Made with Micro-Cleansers

IMPORTANT: Read directions for proper use . 6+ Years

16.9 FL OZ (500mL)

OJLBF-42993-02

ORAJEL ANTICAVITY FLUORIDE RINSE  ALCOHOL AND SUGAR FREE
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-910
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
POLYSORBATE 20 
SODIUM BICARBONATE 
WATER 
SORBITOL 
POLOXAMER 407 
SACCHARIN SODIUM 
FD&C BLUE NO. 1 
GLYCERIN 
SODIUM BENZOATE 
XYLITOL 
CETYLPYRIDINIUM CHLORIDE 
Product Characteristics
Color    Score    
ShapeSize
FlavorFRUIT (Fun-tastic Fruit) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:10237-910-16500 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/05/2015
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIOperations
Church & Dwight Co., Inc253933600manufacture(10237-910)

 
Church & Dwight Co., Inc.

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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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