Orajel Instant Relief for Teething Pain Longer Lasting

Dosage form: gel
Ingredients: BENZOCAINE 75mg in 1g
Labeler: Church & Dwight Co., Inc.
NDC Code: 10237-735

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.

DRUG FACTS

Active ingredients

               
Benzocaine 7.5%                    

Purpose
Oral Pain Reliever

USE
For the temporary relief of sore gums due to teething in children 2 years of age and older.  For use in children under the age of 2, consult a physician or healthcare provider.

Warnings
Allergy Alert:
do not use this product if your child has a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics



Do not use
  • more than directed
  • for more than 7 days unless directed by a physician or healthcare provider

When using this product fever and nasal congestion are not symptoms of teething and may indicate the presence of infection.   If these symptoms persist, consult your physician.

Stop use and ask a doctor if
  • sore mouth symptoms do not improve in 7 days,
  • irritation, pain or redness does not go away,
  • swelling, rash or fever develops

Keep out of reach of children.
In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.

Directions
  • wash hands
  • cut open tip of tube on score mark
  • use your fingertip or cotton applicator to apply a small pea-size amount of Orajel and spread over the gums
  • apply to the affected area up to 4 times daily or as directed by a physician or healthcare provider
  • for children under 2 years of age, consult a physician or healthcare provider

Other information do not use if tube tip is cut prior to opening

Inactive ingredients  cellulose gum, flavor, gelatin, mineral oil, pectin, petrolatum, polyethylene glycol, red 40, sodium saccharin

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

Principal Display Panel

No 1 TEETHING BRAND
        used by Pediatricians

                                                        
                                            Orajel

                                         Instant Relief
                                       for Teething Pain

                                                                                                                cherry flavored gel

                                             

                                 
           LONGER LASTING                                                                            

NET WT 0.33 OZ (9.4g) Gel                     ORAL PAIN RELIEVER FOR TEETHING   BENZOCAINE 7.5%        

Carton image

ORAJEL INSTANT RELIEF FOR TEETHING PAIN  LONGER LASTING
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-735
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE75 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM 
GELATIN 
MINERAL OIL 
PECTIN 
PETROLATUM 
POLYETHYLENE GLYCOL 
FD&C RED NO. 40 
SACCHARIN SODIUM 
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRY (cherry flavored) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:10237-735-185.1 g in 1 TUBE
2NDC:10237-735-121 TUBE (TUBE) in 1 CARTON
23.5 g in 1 TUBE
3NDC:10237-735-421 TUBE (TUBE) in 1 CARTON
311.9 g in 1 TUBE
4NDC:10237-735-331 TUBE (TUBE) in 1 CARTON
49.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/22/2011
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIOperations
Church & Dwight Co., Inc.043690812manufacture

Revised: 03/2012
 
Church & Dwight Co., Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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