ORAJEL KIDS MY WAY ANTICAVITY TOOTHPASTE- 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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Drug Facts

Active ingredient

Sodium fluoride (0.24%)


Purpose

Anticavity toothpaste

Use aids in the prevention of dental decay

Warnings

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

Directions

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

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

Inactive ingredients sorbitol, water, hydrated silica, PEG-8, flavor, cellulose gum, sodium saccharin, sodium lauryl sulfate, red 33.

Question or comments?  Call us at 1-800-952-5080 M-F 9am-5pm ET or visit our website at www.orajel.com

Principal Display Carton

Orajel
4 plus years Kids

My Way

Anticavity Fluroide
Toothpaste

Over 100 Stickers Inside
Decorate Your Toothpaste Your Way

BERRY BLAST


  Decorate Your
Toothpaste Your Way!!                 NEW WT 4.2 OZ (119g)

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ORAJEL  KIDS MY WAY ANTICAVITY TOOTHPASTE
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-740
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorFRUIT (FRUIT BURST FLAVOR) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-740-421 in 1 CARTON
1119 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/01/2012
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Accupac, Inc.071609663manufacture

Revised: 3/2012
Document Id: c3fbca88-f485-41b0-9efc-7b08d18dd51f
Set id: 9e5ea9ef-f54e-4600-af40-44aa86a3a132
Version: 1
Effective Time: 20120322
 
Church & Dwight Co., Inc.