ORAL ANALGESIC  MAXIMUM STRENGTH- benzocaine liquid 
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 due to toothache, 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, benzocaine or other "caine" anesthetics.


Flammable:  keep away from fire or flame. Avoid smoking during applications and until product has dried.

When using this product avoid contact with the eyes, 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    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 imprinted safety seal from bottle cap

Adults and children 2 years of age and over                  Apply product with cotton swab or clean fingertip to the affected area.
                                                                                 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

Inactive ingredients

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

Questions or comments?  call us at 1-800-952-5080 M-F 9am-5pm ET

Meijer

Oral Analgesic Liquid
maximum strength benzocaine 20%

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

Oral Analgesic Liquid
maximum Strength
safety sealed tube tip

NET WT. 0.45 OZ (13.3g)

Carton Image
Carton Image



ORAL ANALGESIC   MAXIMUM STRENGTH
benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-703
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine0.2 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
WATER (UNII: 059QF0KO0R)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41250-703-451 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 finalpart35605/13/2010
Labeler - Meijer Distribution Inc. (006959555)
Registrant - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Accupac071609663manufacture

Revised: 5/2010
Document Id: bd867d71-24cc-47ea-b64a-5c9200ce5a6d
Set id: fd0878b0-1e09-4b55-9d3a-e334a40e00f5
Version: 3
Effective Time: 20100513
 
Meijer Distribution Inc.