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Name:Benzodent
Manufacturer:Chattem, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Benzodent

BENZODENT - benzocaine cream 
Chattem, 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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Benzodent

Drug Facts

Active Ingredient

Benzocaine 20%

Purpose

Pain reliever

Uses

for the temporary relief of pain due to minor irritation of the mouth and gums caused by dentures or orthodontic appliances or injury to mouth and gums

Warnings

Allergy alert: Do not use if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other “caine” anesthetics. Localized allergic reactions may occur after prolonged or repeated use.

Do not use

  • for more than 7 consecutive days unless directed by a dentist or a doctor

When using this product

  • avoid contact with eyes
  • do not exceed the recommended dosage

Stop use and ask a doctor

or dentist 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.

If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 2 years and over:

  • remove cap, break metal seal with cap point
  • apply directly to the gums or to the denture surface that comes in contact with the affected area of the gums
  • if you are using with dentures, wait a few minutes then reinsert dentures and you may use your regular denture adhesive with this product
  • 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: consult a dentist or doctor

Inactive ingredients

cellulose gum, D&C red no. 30 lake, eugenol, FD&C blue no.1 lake, oxyquinoline sulfate, petrolatum (245-003)

PRINCIPAL DISPLAY PANEL

Benzocaine 20%
Benzodent®
NET WT 0.25 OZ (7g)
Dental Pain Relieving Cream

PRINCIPAL DISPLAY PANEL
Benzodent®
NET WT 0.25 OZ (7g)


BENZODENT 
benzocaine cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0053
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 0.2 g  in 1 g
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM  
EUGENOL  
OXYQUINOLINE SULFATE  
PETROLATUM  
D&C RED NO. 30  
FD&C BLUE NO. 1  
ALUMINUM OXIDE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41167-0053-2 1 TUBE (1 TUBE) in 1 CARTON contains a TUBE
1 7 g in 1 TUBE This package is contained within the CARTON (41167-0053-2)
2 NDC:41167-0053-4 1 TUBE (1 TUBE) in 1 CARTON contains a TUBE
2 28 g in 1 TUBE This package is contained within the CARTON (41167-0053-4)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part356 05/12/1994

Labeler - Chattem, Inc. (003336013)
Establishment
Name Address ID/FEI Operations
Chattem Plant 1 003336013 MANUFACTURE, PACK

Revised: 06/2011 Chattem, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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