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BENZODENT (benzocaine) cream
[Chattem, Inc.]


NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKEDTED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.

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)

INGREDIENTS & APPEARANCE

BENZODENT 
benzocaine cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41167-0053
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE0.2 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM 
EUGENOL 
OXYQUINOLINE SULFATE 
PETROLATUM 
D&C RED NO. 30 
FD&C BLUE NO. 1 
ALUMINUM OXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-0053-21 in 1 CARTON
17 g in 1 TUBE
2NDC:41167-0053-41 in 1 CARTON
228 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35605/12/1994
Labeler - Chattem, Inc. (003336013)
Establishment
NameAddressID/FEIBusiness Operations
Chattem Plant 1003336013MANUFACTURE, PACK

Revised: 6/2011
 
Chattem, Inc.