BENZODENT- benzocaine cream

Benzodent by

Drug Labeling and Warnings

Benzodent by is a Otc medication manufactured, distributed, or labeled by Focus Consumer Healthcare, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzocaine 20%

PURPOSE

Pain reliever

INDICATIONS & USAGE

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

Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried to the blood. This can occur even if you have used this product before. Stop use and seek immedicate medical attention if you or a child in your care develops:

• pale, gray or blue colored skin (cyanosis)
• headache
• rapid heart rate
• shortness of breath
• dizziness or lightheadedness
• fatigue or lack of energy

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

Do not use

if you are allergic to aspirin or any other pain reliever/fever reducer

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if

• you have liver disease
  
• the stomach bleeding warning applies to you
  
• you have a history of stomach problems, such as heartburn
  
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  
• you are taking a diuretic

Ask a doctor or pharmacist before use

if you are taking a prescription drug for gout, diabetes or arthritis

Stop use and ask a doctor if

• an allergic reaction occurs. Seek medical help right away.
  
• you experience any of the following signs of stomach bleeding:
  • feel faint
    
  • vomit blood
    
  • have bloody or black stools
    
  • have stomach pain that does not get better

• redness or swelling is present
  
• new symptoms occur
  
• pain gets worse or lasts more than 10 days
  
• fever gets worse or lasts more than 3 days
  
• ringing in the ears or loss of hearing occurs

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION

Adults and children12 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 the 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 12 years: consult a dentist or doctor

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BENZODENT 
benzocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71687-1053
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	0.2 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 30 (UNII: 2S42T2808B)
EUGENOL (UNII: 3T8H1794QW)
ALUMINUM OXIDE (UNII: LMI26O6933)
OXYQUINOLINE SULFATE (UNII: 61VUG75Y3P)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71687-1053-1	1 in 1 CARTON	12/08/2017
1		7 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 71687-1053-2	1 in 1 CARTON	12/08/2017
2		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	12/08/2017

Labeler - Focus Consumer Healthcare, LLC (080743737)