Label: FAMILY WELLNESS REGULAR- benzocaine 10% gel

  • 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 July 2, 2020

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  • Active ingredient

    Benzocaine 10%

  • Purpose

    Oral pain reliever

  • Use

    • for the temporary relief of pain due to toothaches
  • Warnings

    Methemoglobinemla: see package warning.

  • DO NOT USE

    Do not use

    • more than directed
    • for more than 7 days unless directed by a physician or healthcare provider
    • For teething
    • in children under 2 year of age.
  • ASK DOCTOR

    Stop use and ask a physician if

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

    KEEP OUT OF REACH OF CHILDREN:

    In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Directions - cut open tip of tube on score mark

    • Adults and children 2 years of age and over - Apply a samll amount of product to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a physician or healthcare provider
    • Children between 2 and 12 years of age - Should be supervised in the use of this product
    • Children under 2 years of age - Ask a physicaian or healthcare provider
  • Other information

    • do not use if tape seal on the flaps of outer packaging are damaged or miissing
    • Retain outer packaging for full product uses,directions and warnings.
  • Inactive ingredients

    ammonium glycyrrhizate, flavor, polyethylene glycol, sodium saccharin, sorbic acid

  • PRINCIPAL DISPLAY PANEL

    gel1gel2

  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS  REGULAR
    benzocaine 10% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-607
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBIC ACID (UNII: X045WJ989B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76168-607-331 in 1 PACKAGE07/02/2020
    19 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/02/2020
    Labeler - Velocity Pharma LLC (962198409)
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