Label: NENE DENTE- benzocaine liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 Label Information

Updated January 23, 2015

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient                                Purpose

    Benzocaine 7%..................................... Pain Reliever

  • PURPOSE

    Pain Reliever

  • INDICATIONS & USAGE

    Uses For the temporary relief of sore gums due to teething in infants and children 4 months of age and older.

  • WARNINGS

    Warnings: Do not exceed recommended dosage.

    Keep this and all drugs out of the reach of children. Fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms persist, consult your physician.

  • DO NOT USE

    Do not Use:

    • for more than 7 days unless directed but a physician 
    • if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics
  • STOP USE

    Stop Use and see a Doctor

    • if sore mouth symptoms do not improve in 7 days 
    • if irritation, pain or redness persists or worsens
    • if swelling, rash or fever develops
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or  breast-feeding, ask a health professional before use. In case of accidental ingestion, get medical help or contact a Posion Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions: wash hands. Remove imprinted safety seal from bottle. Use your fingertip or cotto swab to apply 2-4 drops. Apply to affected area not more than four times daily or as directed by a physician. For infants under 4 months of age, ther is no recommended dosage or treatment execpt under the advice and supervision of a dentist or physician.

  • OTHER SAFETY INFORMATION

    Other information: Store this product between 15-30 C (59-86 F). Do not use if printed plastic bottle wrap is broken, toen or missing prior to opening. Save outer carton for full directions and warnings.

  • INACTIVE INGREDIENT

    Inactive ingredients: Cherry flavor, Glycerin, Propylene Glycol, Propylparaben, Menthol, Methylparaben.

  • PRINCIPAL DISPLAY PANEL

    Nene Dente Label

  • INGREDIENTS AND APPEARANCE
    NENE DENTE 
    benzocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-335
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE2.1 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53145-335-011 in 1 CARTON
    130 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/01/2014
    Labeler - Menper Distributors, Inc (101947166)