Label: ORAL PAIN RELIEF GEL- benzocaine 20% 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 March 25, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Benzocaine 20% (w/w)

  • PURPOSE

    Purpose

    Oral anesthetic

  • INDICATIONS & USAGE

    Uses

    For the temporary relief of minor pain and sore mouth associated with toothache, minor dental procedures and irritations from dentures or orthodontic appliances.

  • WARNINGS

    Warnings

    For oral use only.

  • DO NOT USE

    stop use and ask a doctor if get any discomfort.

  • STOP USE

    Stop use and ask a dentist or doctor if

    • sore mouth does not improve in 7 days
    • irritation, pain, or redness persists or worsens
    • swelling, rash, fever or other allergic reaction develops
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If accidentally swallowed get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children (2 years and older):

    Dry affected area and apply medication undiluted. Use up to 4 times daily, but not more than every two hours, or as directed by a dentist or doctor.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Polyethylene Glycol, Fragrance

  • PRINCIPAL DISPLAY PANEL

    Benzocaine 20% | Oral Anesthetic

    NET WT 0.75 g

    label image

  • INGREDIENTS AND APPEARANCE
    ORAL PAIN RELIEF GEL 
    benzocaine 20% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81417-121
    Route of AdministrationTOPICAL
    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, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81417-121-011 in 1 PACKAGE03/25/2022
    10.75 g in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35603/25/2022
    Labeler - Sled Distribution, LLC (079772888)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sled Distribution, LLC079772888manufacture(81417-121)
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