ORAL ANALGESIC MAXIMUM STRENGTH- oral pain reliever gel 
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

Uses

Uses    temporarily relieves pain associated with:

toothache         minor dental procedures

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.

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 physician if    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

Directions  

do not use if tube is cut prior to opening;  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 a dentist or physician

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  This preparation is intended for use in case of toothache, only as a temporary expedient until a dentist can be consulted. Do not use continuously.

Inactive ingredients

Inactive ingredients  flavor, polyethylene glycol, sodium saccharin, sorbic acid

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

Orajel         gel

Instant Pain Relief

for TOOTHACHE

MAXIMUM STRENGTH



NE WT 0.42 OZ (11.9 g)     ORAL PAIN RELIEVER   BENZOCAINE 20%


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ORAL ANALGESIC  MAXIMUM STRENGTH
oral pain reliever gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-701
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
polyethylene glycol (UNII: 3WJQ0SDW1A)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
sorbic acid (UNII: X045WJ989B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41250-701-251 in 1 CARTON
17.1 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: 51e14b50-af28-4132-873a-37e904549c1d
Set id: 5372eea1-afd5-4bde-8d76-f6b0aaffc199
Version: 3
Effective Time: 20100513
 
Meijer Distribution, Inc.