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Orajel Maximum Strength by Church & Dwight Co., Inc.

Dosage form: cream
Ingredients: BENZOCAINE 200mg in 1g, MENTHOL 2.5mg in 1g
Labeler: Church & Dwight Co., Inc.
NDC Code: 10237-706

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          Purpose
Benzocaine20%                  Oral pain reliever
Menthol 0.25%                    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, benzcaine or other "caine" anesthetics

Do not use
more than is directed
for more than 7 days unless told to do so 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, get medical help or contact a Poison Control Center right away


Directions

Directions    cut open tip of tube on score mark

Adults and children 2 years of age and over            Apply a small amount of product to the cavity and around gum surrounding the teeth.
                                                                           Use up to 4 times daily or as directed by dentist or doctor.

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

Children under 2 years of age                                 Ask a dentist or doctor



Other information

do not use if tube tip is cut 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
Orajel PM will stay in place for extended duration of relief



Inactive ingredients cellulose gum, gelatin, methyl salicylate, pectin, plasticized hydrdocarbon gel, polyethylene glycol, sodium saccharin

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

Orajel PM       Cream

Instant Pain Relief

for SEVERE TOOTHACHE

MAXIMUM STRENGTH

Long Lasting Formula for Nighttime


net wt 0.25 OZ (7.0 G)   ORAL PAIN RELIEVER

carton image



ORAJEL  MAXIMUM STRENGTH
benzocaine and menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-706
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE200 mg  in 1 g
MENTHOL (MENTHOL) MENTHOL2.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM 
POLYETHYLENE GLYCOL 
SACCHARIN SODIUM 
GELATIN 
METHYL SALICYLATE 
PECTIN 
MINERAL OIL 
Packaging
#Item CodePackage Description
1NDC:10237-706-251 TUBE (TUBE) in 1 CARTON
17.0 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/10/2010
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIOperations
Church & Dwight Co., Inc.043690812manufacture

Revised: 05/2010
 
Church & Dwight Co., Inc.

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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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