Label: IPANA 20% BENZOCAINE TOPICAL- benzocaine 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 January 13, 2022

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

  • Active Ingredients (in each gram)

    Benzocaine 200mg

  • Purpose

    Oral Anesthetic

  • Use

    For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.

  • Warnings

    ​Allergy alert: ​Do not use on patients with a history of allergies to local anesthetics such as benzocaine or other "caine" anesthetics. 

    ​Do not use ​for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly.

    ​When using this product ​avoid contact with eyes. If contact occurs, flush with water.

    ​Stop use and consult a health care practitioner ​if the following symptoms appear: weakness, confusion, headache, difficulty breathing, and/or pale, grey or blue colored skin, as these may be signs of methemoglobinemia, a rare disorder, which may appear up to 2 hours after use.

    ​Do not exceed recommended dosage. ​If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately. 

    ​If pregnant or breastfeeding, ​ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    ​Keep out of reach of children.

  • Directions

    Apply only amount needed to the oral mucosa to prevent or relieve pain.

  • Other Information

    Store at 59°-86°F (15°-30°C). Protect from freezing.

  • Inactive Ingredients

    flavoring, PEG 3350, PEG 400, sodium saccharin. May contain yellow #5 (tartrazine), yellow #6, red #3, red #40, blue #1, green #3 as a color additive.

  • Questions?

    1-855-462-9455 or 1-519-631-7370

  • PRINCIPAL DISPLAY PANEL

    LB.ipana-Topical-Gel-Wrap_US.jpg

  • INGREDIENTS AND APPEARANCE
    IPANA 20% BENZOCAINE TOPICAL 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69510-358
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorSTRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69510-358-3028 g in 1 JAR; Type 0: Not a Combination Product08/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35608/01/2016
    Labeler - Maxill Inc. (079343581)