ORAJEL FLUORIDE- sodium fluoride gel, dentifrice 
Church & Dwight Co., Inc.

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 Toothpaste

Sodium Fluoride (0.24%)

Anticavity Toothpaste

Use

Aids in the prevention of dental decay

Warnings

Keep our 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.

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

Bubble Berry

Orajel

Anticavity

Fluoride

Toothpaste

Disney

Elena

Avalor

NET WT 4.2 OZ (119g)

OJTU-00017-01 (002).jpg

ORAJEL FLUORIDE 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-773
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION6 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorBERRY (Bubble Berry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-773-421 g in 1 TUBE; Type 0: Not a Combination Product10/24/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/24/2017
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Church & Dwight Co., Inc.043690812manufacture(10237-773)

Revised: 10/2017
Document Id: 5c4ff036-711b-373a-e053-2a91aa0a756a
Set id: 5c4ff036-711a-373a-e053-2a91aa0a756a
Version: 1
Effective Time: 20171024
 
Church & Dwight Co., Inc.