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 doctor

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

Inactive ingredients sorbitol, water, hydrated silica, PEG-32, flavor, cellulose gum, sodium saccharin, sodium lauryl sulfate, blue 1.

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 OJKFC-32370-01

Orajel Kids
My Way

Anticavity Fluroide Toothpaste

Over 100 Stickers Inside
Decorate Your Toothpaste Your Way

Fruit Burst Flavor

WARNING:
CHOKING HAZARD-
Small parts. Not for                    NEW WT 3 OZ (85g)
children under 3 years.

Carton image
Carton image
ORAJEL  KIDS MY WAY ANTICAVITY TOOTHPASTE
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-728
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)  
PEG-32 STEARATE (UNII: 33GX5WQC0M)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorFRUIT (FRUIT BURST FLAVOR) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-728-301 in 1 CARTON
185 g in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/01/2011
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Accupac, Inc.071609663manufacture

Revised: 3/2011
Document Id: 493f60ce-a42c-4ce5-9970-9f50c2a57ae2
Set id: 49916438-fbad-4901-b820-e233633cba83
Version: 1
Effective Time: 20110324
 
Church & Dwight Co., Inc.