BENZODENT- benzocaine cream 
Focus Consumer Healthcare, LLC

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Benzodent

Benzocaine 20%

Pain reliever

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.

Adults and children12 years and over:

children under 12 years: consult a dentist or doctor

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:

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

  • for more than 7 consecutive days unless directed by a dentist of a doctor
  • for teething
  • in children under 2 years of age

When using this product

  • avoid contact with eyes
  • do not exceed recommended dosage

Stop use and ssk 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.

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.

cellulose gum, D&C red no.30 lake, eugneol, FD&C blue no. 1 lake, oxyquinoline sulfate, petrolatum

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BENZODENT 
benzocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71687-1053
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE0.2 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71687-1053-11 in 1 CARTON12/08/2017
17 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:71687-1053-21 in 1 CARTON12/08/2017
228 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01712/08/2017
Labeler - Focus Consumer Healthcare, LLC (080743737)

Revised: 12/2023
Document Id: 0c531868-c719-7bfe-e063-6394a90ae461
Set id: 5fdcb871-d387-6352-e053-2991aa0a09da
Version: 6
Effective Time: 20231212
 
Focus Consumer Healthcare, LLC