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CVS Pharmacy Toothache and Gum Reliever

Dosage form: gel, dentifrice
Ingredients: BENZOCAINE 20.00g in 100g, Benzalkonium Chloride 0.1g in 100g, MENTHOL 0.25g in 100g
Labeler: CVS Pharmacy
NDC Code: 69842-350

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 ingredient

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

Menthol 0.25% ....................................................Oral Pain Reliever

Benzalkonium Chloride 0.1% ..................................Antiseptic

Uses

for the temporary relief of pain due to toothaches

to help against infection of minor oral irritation

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. This formula will stay in place for an extended duration of relief. Avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying.

Inactive ingredients

Cellulose Gum, Gelatin, Methyl Salicylate, Mineral Oil, Pectin, Petrolatum, Polyethylene Glycol, Sodium Saccharin

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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CVS PHARMACY  TOOTHACHE AND GUM RELIEVER
benzocaine gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-350
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE20.00 g  in 100 g
Benzalkonium Chloride (BENZALKONIUM) Benzalkonium Chloride0.1 g  in 100 g
MENTHOL (MENTHOL) MENTHOL0.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Petrolatum 
Mineral Oil 
SACCHARIN SODIUM 
Gelatin 
Polyethylene Glycols 
Methyl Salicylate 
Pectin 
Carboxymethylcellulose Sodium 
Product Characteristics
Colorwhite (off white to beige/tan) Score    
ShapeSize
FlavorWINTERGREEN (Characteristic; Wintergreen) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:69842-350-901 TUBE in 1 CARTON
1NDC:69842-350-209.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35611/01/2016
Labeler - CVS Pharmacy (062312574)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIOperations
Lornamead126440440manufacture(69842-350), pack(69842-350)

Revised: 01/2017
 
CVS Pharmacy

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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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