Your browser does not support JavaScript! ORAJEL MAXIMUM STRENGTH (BENZOCAINE) LIQUID [CHURCH & DWIGHT CO., INC.]
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ORAJEL MAXIMUM STRENGTH (benzocaine) liquid
[Church & Dwight Co., Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

Active ingredient

Benzocaine 20%

Purpose

Oral pain reliever

Use for the temporary relief of pain due to toothaches

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 application and until product has dried
                                                                                                                                                                              

Do not use

  • more than directed
  • for more than 7 days unless directed by a dentist or doctor                   
                                                                                                                                                                                    

Stop use and ask a doctor if

  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens
  • symptoms do not improve in 7 days
                                                                                                                                                                                              

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

  • remove imprinted safety seal from bottle cap
                                                                                                                                                                                                                                                                                    
Adults and children 2 years and older                 Apply product with cotton swab or finger to the cavity and around gum surrounding the teeth.  Use up to 4 times daily or as directed by a dentist                                                                                                            or doctor 
                                                                                                                                                                                                                                                                                       

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
                                                                                                                                                                                                                                                                                                                   

Other information

  • do not use if imprinted bottle seal is broken or missing prior to opening
  • this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted
  • do not use continuously

Inactive ingredients  alcohol (54.6% by volume), flavor, polyethylene glycol, purified water, red 40, sodium saccharin, yellow 5

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


#1 ORAL PAIN RELIEVER
     FOR TOOTHACHE


Orajel                     liquid
Instant Pain Relief

for TOOTHACHE

MAXIMUM STRENGTH
NET CONTENTS 0.45 FL OZ (13.3 ML)     ORAL PAIN RELIEVER         BENZOCAINE 20%


Carton imageCarton image

ORAJEL  MAXIMUM STRENGTH
benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-703
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (Benzocaine) Benzocaine0.2 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
POLYETHYLENE GLYCOL 400 
SACCHARIN SODIUM 
Packaging
#Item CodePackage Description
1NDC:10237-703-451 in 1 CARTON
113.3 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35604/01/2010
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Accupac, Inc.071609663manufacture

Revised: 03/2011
Document Id: 52266132-3a1c-471d-96a3-a8e1c0c4bdaf
Set id: 8ce643ea-5f8d-4ae9-b1ff-6b04196f4b4f
Version: 5
Effective Time: 20110315
 
Church & Dwight Co., Inc.

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