ORAJEL KIDSTOOTHPASTE- sodium fluoride paste, 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 Mermaid and Unicorn Fluoride Toothpaste

Active ingredient

Sodium fluoride 0.24%

Purpose

Anticavity toothpaste

Use

aids in the prevention of dental decay

Warnings

Warnings

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

Children under 6 years

Children under 2 years

Inactive ingredients

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

Warnings

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Principal Display Panel

Mixed Berry

Orajel

Anticavity

Fluoride

Toothpaste

magical unicorns OR mermaid

NET WT 4.2 OZ (119 g)

CR_DA2039905_OJTU-43018-01-MER_72016734CR_DA2039904_OJTU-43018-01-UNI_72016735

ORAJEL KIDSTOOTHPASTE 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-785
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
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SORBITOL (UNII: 506T60A25R)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-785-42119 g in 1 TUBE; Type 0: Not a Combination Product01/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35511/01/2019
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Church & Dwight Co., Inc.043690812MANUFACTURE(10237-785)

Revised: 1/2023
Document Id: 05b305ef-8eda-480d-97df-17456966159d
Set id: 99d62125-c2c5-5926-e053-2995a90aaa29
Version: 4
Effective Time: 20230110
 
Church & Dwight Co., Inc.