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Oral Analgesic Maximum Strength

Dosage form: paste
Ingredients: BENZOCAINE 200mg in 1g, MENTHOL 2.5mg in 1g
Labeler: Meijer Distribution Inc.
NDC Code: 41250-706

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:

canker sores, cold sores, fever blisters, minor irritation of the mouth and gums caused by dentures or orthodontic appliances

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

When using this product
do not use more than directed
do not use for more than 7 days unless directed by a doctor/dentist
do not use more than 4 times in a 24 hour period unless directed by a doctor/dentist

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

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


Directions

Directions   

remove cap and cut tip of the tube on score mark
adults and children 2 years of age and over:  apply to tyhe affected area up to 4 times daily or as directed by doctor/dentist
children under 12 years of age: should be supervised in the use of this product
Children under 2 years of age:  ask a doctor/dentist

Other information

Do not use if tube tip is cut prior to opening.

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

meijer
Oral Analgesic Paste
maximum strength

For Fast Relief of Oral Pain Caused by:
Toothache, Denture, or Gum Irritations,
Cold or Canker sores

Oral Analgesic Paste
maximum strength
safety sealed tube tip

MET WT. 0.21 oz (6g)



carton image

ORAL ANALGESIC   MAXIMUM STRENGTH
benzocaine and menthol paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-706
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:41250-706-211 TUBE (TUBE) in 1 CARTON
16.0 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/13/2010
Labeler - Meijer Distribution Inc. (006959555)
Registrant - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIOperations
Church & Dwight Co., Inc.043690812manufacture

Revised: 05/2010
 
Meijer Distribution 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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