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Orajel Fluoride by Church & Dwight Co., Inc.

Medically reviewed on December 13, 2016

Dosage form: gel, dentifrice
Ingredients: SODIUM FLUORIDE 6mg in 1g
Labeler: Church & Dwight Co., Inc.
NDC Code: 10237-763

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.

Orajel Anticavity

Sodium Fluoride (0.24%)

Anticavity Toothpaste

Use aids in the prevention of dental decay

Keep out of reach of children under 6 years of age.

If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.

Directions:

twist off cap and remove foil seal

do not swallow

supervise children as necessary until capable of using without supervision

adults and children 2 years and older - brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician

children under 6 years - instruct in good brushing and rinsing habits (to minimize swallowing)

children under 2 years - ask a dentist or physician

sorbitol, water, hydrated silica, PEG-8, flavor, cellulose gum, sodium saccharin, sodium lauryl sulfate, blue 1

Questions or comments Call us at 800 952 5080 Monday through Friday 9 - 5 ET or visit our website at www orajel com

Berry Divine

Orajel ™

Anticavity

Fluoride

Toothpaste

Shimmer and Shine

NET WT. 4.2 OZ (119g)

Nickelodeon

ORAJEL FLUORIDE 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-763
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION6 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SODIUM LAURYL SULFATE 
SACCHARIN SODIUM 
FD&C BLUE NO. 1 
SORBITOL 
HYDRATED SILICA 
POLYETHYLENE GLYCOL 400 
CARBOXYMETHYLCELLULOSE SODIUM 
WATER 
Product Characteristics
ColorblueScore    
ShapeSize
FlavorBERRY (Berry Devine) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:10237-763-42119 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/10/2016
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIOperations
Church & Dwight Co., Inc.043690812manufacture(10237-763)

 
Church & Dwight Co., Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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