Label: PAIN RELIEF- benzocaine liquid

  • NDC Code(s): 61010-8100-1, 61010-8100-2
  • Packager: Safetec of America, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 16, 2024

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  • Active Ingredients

    Benzocaine 20% (w/w)

  • Purpose

    Oral pain reliever

  • Uses

    temporarily relieves pain caused by

    • toothache
    • dental work
    • minor irritation or injury of the mouth and gums
    • canker sores
    • gum sores
    • cheek bites
    • denture irritation
  • Warnings

    For oral use only.Avoid contact with eyes.

    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 blood. This can occur even if you have used this product before. Stop use and seek immediate attention if you or a child in your care develops:

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

    • for teething
    • in children under 2 years of age

    When using this product

    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; if irritation, pain or redness persists or worsens; or if swelling, rash, fever or other allergic reaction develops, see your doctor or dentist promptly. Do not exceed recommended dosage.

    Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 2 years of age 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 of age: do not use
  • Other Information

    • Do not use if packet is torn, cut, or opened
    • Store at room temperature, 15º to 30ºC (59º to 86ºF)
    • Avoid contact with eyes
  • Inactive ingredients

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

  • Questions or Comments?

    1-800-456-7077

  • Principal Display Panel - Safetec Oral Pain Relief Carton Label

    NDC 61010-800-1

    Safetec

    First Aid

    Oral Pain Relief

    Fast mouth sore relief for:

    Canker Sores

    Gum Pain

    Toothache

    Dental Work

    Reorder No. 53117

    To reorder:

    Call: 1-800-456-7077

    Fax: 716-895-2969

    Online: www.safetec.com

    Principal Display Panel - Safetec Oral Pain Relief Carton Label
  • Principal Display Panel - Safetec Oral Pain Relief Packet Label

    Safetec

    Oral Pain Relief

    0.75 g (1/38 oz.)

    Safetec of America, Inc.

    Buffalo, NY 14215

    800-456-7077

    Principal Display Panel - Safetec Oral Pain Relief Packet Label
  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF 
    benzocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-8100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBIC ACID (UNII: X045WJ989B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61010-8100-20.5 g in 1 PACKET; Type 0: Not a Combination Product02/01/2019
    2NDC:61010-8100-1144 in 1 BOX02/01/2019
    20.75 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/01/2010
    Labeler - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec Of America, Inc.874965262manufacture(61010-8100)
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