ORAJEL- 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%)

(0.15% w/v fluoride ion)

Anticavity

Aids in the prevention of dental decay

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

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

Directions

adults and children 2 years and olderbrush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician
children under 6 yearsinstruct in good brushing and rinsing habits (to minimize swallowing)
children under 2 yearsask a denist or physician

Sorbitol (corn), Water, Hydrated Silica (mineral), Glycerin (vegetable), Cellulose Gum (tree pulp/cotton seed), Cocamidopropyl Betaine (coconut-derived), Stevia Rebaudiana Leaf Extract (stevia), Natural Flavor. All active ingredients are described in the format "ingredient name (source)".

Questions of comments? Call us at 1-800-952-5080 M-F 9am - 5pm ET or visit our website at orajelkids.com

JURASSIC WORLD

Stage

3

2-10 YEARS

Orajel™

kids

NATURALLY

SOURCED*

anti•cavity

TOOTHPASTE

fluoride

NATURAL

BERRY

BLAST

OUR

COMMITMENT

CERTIFIED RENEWABLE ENERGY

Green-e®

PROUD SUPPORTER OF

Arbor Day

Foundation®

PLASTIC

TUBE

how2recycle.info

SCAN ME

NET WT 4.2 OZ (119 g)

Orajel Jurassic Kids Toothpaste.jpg

ORAJEL 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-775
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
SORBITOL (UNII: 506T60A25R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorblue (Berry) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-775-42119 g in 1 TUBE; Type 0: Not a Combination Product07/20/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/20/2018
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Church & Dwight Co., Inc.043690812manufacture(10237-775)

Revised: 2/2022
Document Id: d773b056-3d17-c8f3-e053-2a95a90af889
Set id: 71713187-f51b-fcf1-e053-2995a90abe69
Version: 4
Effective Time: 20220207
 
Church & Dwight Co., Inc.