ORAJEL KIDS MY WAY ANTICAVITY- 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 Kids My Way Fruit Splash Toothpaste

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: 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

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, blue 1.

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

Principal Display Carton

Orajel

4 plus years Kids

My Way

Anticavity Fluroide

Toothpaste

Over 100 Stickers Inside

FRUIT

SPLASH



Decorate Your

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

Carton image

Carton image

ORAJEL  KIDS MY WAY ANTICAVITY
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-743
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.4 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)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorFRUIT (FRUIT SPLASH) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-743-421 in 1 CARTON02/01/201305/10/2016
1119 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/01/201305/10/2016
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Accupac, Inc.071609663manufacture(10237-743)

Revised: 12/2019
 
Church & Dwight Co., Inc.