ORAL ANALGESIC  MAXIMUM STRENGTH- benzocaine and menthol paste 
Meijer Distribution 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          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
carton image

ORAL ANALGESIC   MAXIMUM STRENGTH
benzocaine and menthol paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-706
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
GELATIN (UNII: 2G86QN327L)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
PECTIN (UNII: 89NA02M4RX)  
MINERAL OIL (UNII: T5L8T28FGP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41250-706-211 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/FEIBusiness Operations
Church & Dwight Co., Inc.043690812manufacture

Revised: 5/2010
Document Id: 69f354c4-fa32-48e6-95e6-8a754e8bdbd0
Set id: 057d51ea-c66e-4246-ba53-b03b288dbe5b
Version: 2
Effective Time: 20100513
 
Meijer Distribution Inc.