CVS PHARMACY INSTANT TOOTHACHE- benzocaine gel, dentifrice 
CVS Pharmacy

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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CVS Pharmacy Instant Toothache

Active ingredient

Benzocaine 20.0% ..................................Purpose: Oral pain reliever

Uses

for 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

  • 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, 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

• cut open tip of tube on scoremark

  • Adults and children 2 years of age and older: apply a small amount of product to the cavity and around the the gum surrounding the teeth. 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 tip is cut prior to opening. this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted. Do not use continuously.

Inactive ingredients

Flavor, Polyethylene Glycol, Sodium Saccharin, Sorbic Acid

Adults and children 2 years of age and older: apply a small amount of product to the cavity and around the the gum surrounding the teeth. 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.

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Carton label

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Tube Label

CVS PHARMACY  INSTANT TOOTHACHE
benzocaine gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-931
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBIC ACID (UNII: X045WJ989B)  
Product Characteristics
Colorwhite (White to Pinkish orange) Score    
ShapeSize
FlavorMINT (Eucalyptus Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-931-191 in 1 CARTON10/01/201202/15/2019
1NDC:59779-931-1214 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B10/01/201202/15/2019
Labeler - CVS Pharmacy (062312574)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead Inc.078584069manufacture(59779-931)

Revised: 2/2019
 
CVS Pharmacy