Orajel Anticavity Fluoride Rinse - Bubble Burst

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 - Bubble Burst

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, flavor, benzyl alcohol, sodium bicarbonate, sodium benzoate, xylitol, cetylpyridinium chloride, sodium saccharin, red 33

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

Bubble Burst

• 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-42994-01

ORAJEL ANTICAVITY FLUORIDE RINSE  ALCOHOL AND SUGAR FREE
sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62864-909
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
GLYCERIN (UNII: PDC6A3C0OX)
BENZYL ALCOHOL (UNII: LKG8494WBH)
XYLITOL (UNII: VCQ006KQ1E)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM (Bubble Burst)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62864-909-16	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/05/2015	05/10/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	10/05/2015	05/10/2016

Labeler - Church & Dwight Canada Corp. (253933600)

Registrant - Church & Dwight Co., Inc. (001211952)

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Co., Inc		253933600	manufacture(62864-909)

Revised: 12/2019

Document Id: 9b04479c-0dcc-3c12-e053-2995a90afeab

34390-5

Set id: 2171d5ca-c0a9-5ec7-e054-00144ff88e88

Version: 2

Effective Time: 20191231

 

Church & Dwight Canada Corp.