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

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

OJTU-42999-01

ORAJEL FLUORIDE 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-763
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorBERRY (Berry Devine) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-763-42119 g in 1 TUBE; Type 0: Not a Combination Product12/10/2016
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/FEIBusiness Operations
Church & Dwight Co., Inc.043690812MANUFACTURE(10237-763)

Revised: 1/2023
Document Id: 9e05d17d-afe9-4f67-bcbc-fe02bb888a70
Set id: 438ae02a-dcf4-38c9-e054-00144ff8d46c
Version: 3
Effective Time: 20230110
 
Church & Dwight Co., Inc.