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Instant Toothache Pain Relief

Dosage form: liquid
Ingredients: BENZOCAINE 20g in 100g
Labeler: CVS Pharmacy
NDC Code: 59779-831

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 ingredientBenzocaine 20.0%  ...................................................................... Oral pain reliever

Usefor the temporary relief of pain due to toothaches

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 flame or fire. Avoid smoking during application and until product has dried

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 doctor - 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.

Directionsdo not use if package has been opened - adults and children 2 years of age and
older:
using applicator tip, apply to the cavity and around the gum surrounding the teeth. Use up to 4
times daily or as directed by a dentist or doctor. Children 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 InformationThis preparation is intended for use in cases of toothache, only as a
temporary expedient until a dentist can be consulted. Do not use continiously.

Inactive ingredientsEthyl Alcohol 44.2% by weight, Red 40, Yellow 5, Flavor,
Polyethylene Glycol, Water, Sodium Saccharin




• 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: consult a dentist or doctor
INSTANT TOOTHACHE PAIN RELIEF 
benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-831
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL41.99 g  in 100 g
POLYETHYLENE GLYCOL 40034.5 g  in 100 g
SACCHARIN SODIUM0.5 g  in 100 g
FD&C RED NO. 400.001 g  in 100 g
FD&C YELLOW NO. 50.002 g  in 100 g
WATER2.507 g  in 100 g
Product Characteristics
Color    Score    
ShapeSize
FlavorCOCONUT (Pina Colada Flavor #26041) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:59779-831-291 BOTTLE, WITH APPLICATOR (BOTTLE) in 1 CARTON
1NDC:59779-831-2114.17 g in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B10/01/2009
Labeler - CVS Pharmacy (062312574)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIOperations
Lornamead126440440manufacture, pack

Revised: 04/2011
 
CVS Pharmacy

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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