Orajel Anticavity Fluoride Rinse - Fruit Splash

Orajel Anticavity Fluoride Rinse by

Drug Labeling and Warnings

Orajel Anticavity Fluoride Rinse by is a Otc medication manufactured, distributed, or labeled by Church & Dwight Canada Corp., Church & Dwight Co., Inc., Church & Dwight Co., Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ORAJEL ANTICAVITY FLUORIDE RINSE ALCOHOL AND SUGAR FREE- sodium fluoride liquid 
Church & Dwight Canada Corp.

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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Orajel Anticavity Fluoride Rinse - Fruit Splash

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, benzyl alcohol, 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

NEW

Orajel

Anticavity Fluoride Rinse

Alcohol & Sugar Free

Fruit Splash Super Mario

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

IMPORTANT: Read directions for proper use .

16.9 FL OZ (500mL)

OJLBFB-42993-01OJLBFB-42993-01

ORAJEL ANTICAVITY FLUORIDE RINSE  ALCOHOL AND SUGAR FREE
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 62864-910
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCERIN (UNII: PDC6A3C0OX)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
XYLITOL (UNII: VCQ006KQ1E)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
Product Characteristics
Color    Score    
ShapeSize
FlavorFRUIT (Fruit Splash) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 62864-910-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product10/05/201511/23/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/05/201511/23/2019
Labeler - Church & Dwight Canada Corp. (253933600)
Registrant - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Church & Dwight Co., Inc253933600manufacture(62864-910)

Revised: 12/2019
 
Church & Dwight Canada Corp.