Label: MCKESSON ORASOL GEL- benzocaine 20% gel

  • NDC Code(s): 68599-8247-4
  • Packager: McKesson Medical-Surgical
  • Category: HUMAN OTC DRUG LABEL

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 October 25, 2022

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • 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 exceed recommended dosage.

    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 in the blood. This can occur even if you have used this product before.

    Stop use and seek medical attention if you or a child in your care develops:

    • pale, gray or blue colored skin (cyanosis)
    • rapid heart rate
    • dizziness or lightheadedness
    • headache
    • shortness of breath
    • fatigue or lack of energy

    Allergy alert:

    Do not use this product if you have a history of allergy to local anesthetics, such as procaine, butacaine, benzocaine, or other “caine” anesthetics. If a skin reaction occurs, stop use and seek medical help right away.

  • DO NOT USE

    Do not use

    • for teething - any teething related indication will not be ab appropriate use of this product
    • in children under 2 years of age
    • for more than 7 days unless directed by a doctor
  • 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
  • WHEN USING

    When using this product

    • avoid contact with eyes
  • 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.

    Children under 2 years:

    Do not use

  • OTHER SAFETY INFORMATION

    Other information

    • do not use if packet is torn, cut or opened
    • store at room temperature: 59° to 86°F (15° to 30°C)
    • tamper evident sealed packets
  • INACTIVE INGREDIENT

    Inactive ingredients

    PEG 400, PEG 3350, peppermint oil, sodium saccharin, sorbic acid

  • QUESTIONS

    Questions or comments? Call 1-800-777-4908

  • PRINCIPAL DISPLAY PANEL

    NDC 68599-8247-4

    McKesson

    Orasol Gel

    Individual Packets

    Benzocaine 20% | Oral Anesthetic

    Temporary relief of minor pain and sore mouth.

    NET WT 0.75 g

    75 Packs Per Box

    Do Not Reuse

    MFR # 82474

    McKesson

  • INGREDIENTS AND APPEARANCE
    MCKESSON ORASOL GEL 
    benzocaine 20% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-8247
    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 3350 (UNII: G2M7P15E5P)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBIC ACID (UNII: X045WJ989B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68599-8247-475 in 1 BOX10/04/2021
    10.75 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35610/04/2021
    Labeler - McKesson Medical-Surgical (023904428)
    Registrant - Unifirst First Aid Corporation (832947092)