EXTRA STRENGTH PAIN RELIEF- benzocaine and menthol 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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ACTIVE INGREDIENTS            PURPOSE

Benzocaine 15%                     Oral Pain Reliever
Menthol 2%                             Oral Pain Reliever

Uses   for the temporary relief of pain associated with  minor irritation or injury of the mouth and gums; canker sores

Warnings

Allergy alert:  do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

Flammable:  keep away from fire or flame. Avoid smoking during applications and until product has dried.

Do not use
  more than directed; for more than 7 days unless told to do so by a dentist or doctor

Stop use and ask a doctor if
sore mouth symptoms do not improve in 7 days; swelling, rash or fever develops; irritation , pain or redness persists or worsens

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

Directions  
cut open tip of tube on score mark
do not use if tube tip is cut prior to opening
do not peel off protective
use up to 4 times daily or as directd by a dentist or doctor

Adults and children 2 years of age and over                        Dry affected area.  Apply product with cotton swab or clean finger.
                                                                                       Allow get to dry for 30-60 seconds into protective film.

Children under 12 years of age                                           Should be supervised in the use of this product

Children under 2 years of age                                             Ask a dentist or doctor

Inactive ingredients  acesulfame potassium, alcohol (76.4% by volume), ethylcellulose, flavor, polycarbophil, purified water

Questions or comments?  call us at 1-800-92-5080 M-F 9am-5pm ET or visit our website at www.orajel.com

Orajel Instant Pain Relief

for Canker Sores

film forming gel


Carton image

Carton image

  EXTRA STRENGTH PAIN RELIEF
benzocaine menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-707
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE150 mg  in 1 g
MENTHOL (MENTHOL) MENTHOL20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ACESULFAME  
ALCOHOL 
ETHYLCELLULOSE 
POLYCARBOPHIL 
WATER 
Packaging
#Item CodePackage Description
1NDC:10237-707-331 in 1 CARTON
19.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/29/2010
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Accupac071609663manufacture

Revised: 07/2010
 
Church & Dwight Co., Inc.