ORAJEL NIGHTTIME INSTANT RELIEF FOR TEETHING PAIN LONGER LASTING EXTRA STRENGTH- benzocaine gel 
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 Ingredients

Benzocaine 10%

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 baby has a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

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

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 symptoms of teething and may indicate the presence of infection. If these symptoms persists, consult your physician

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

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

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

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

Nighttime

Orajel™

Instant Relief

for Teething PAin

Longer Lasting Extra Strength for Nighttime

Oral Pain Relieverfor Teething Benzocaine 10%

NET WT 0.18 OZ (5.1 g) GEL

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ORAJEL NIGHTTIME INSTANT RELIEF FOR TEETHING PAIN  LONGER LASTING EXTRA STRENGTH
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-738
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
GELATIN (UNII: 2G86QN327L)  
MINERAL OIL (UNII: T5L8T28FGP)  
PECTIN (UNII: 89NA02M4RX)  
PETROLATUM (UNII: 4T6H12BN9U)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRY (Cherry Flavored) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-738-181 in 1 CARTON06/18/201006/01/2018
15.1 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/18/201006/01/2018
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Church & Dwight Co., Inc.043690812manufacture(10237-738)

Revised: 1/2017
 
Church & Dwight Co., Inc.