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Pain Relief (Safetec of America, Inc.)

Available Formats

Dosage Form Package Information Links
LIQUID .5 g in 1 PACKET (61010-8100-2) Label Information
LIQUID 144 PACKET in 1 BOX (61010-8100-1) > .75 g in 1 PACKET Label Information

Complete Pain Relief Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • 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
    • cheek bites
    • gum sores
    • denture irritation

  • Warnings

    For oral use only. Avoid contact with eyes.

    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 due to the possibility of anaphylactic shock.

    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

    If more than used for pain relief is accidentally swallowed, get medical help or contact a Poison Control Center right away.


  • 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.
    • consult a dentist or doctor for use on children under 2 years of age
    • children under 12 years of age should be supervised in the use of this product

  • 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

    Manufactured by
    SAFETEC OF AMERICA, Inc.
    Buffalo, NY 14215. 800-456-7077

    www.safetec.com


  • Principal Display Panel – 0.75 gram, 144 Packets Box Label

    NDC 61010-8100-1

    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 – 0.75 gram, 144 Packets Box Label

  • Principal Display Panel – 0.5 gram Packet

    Safetec

    Oral Pain
    Relief
    0.5 g (1/57 oz.)

    Safetec of America, Inc.
    Buffalo, NY 14215
    800-456-7077

    Principal Display Panel – 0.5 gram Packet

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF 
    benzocaine liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:61010-8100
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    benzocaine (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5) benzocaine 200 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    polyethylene glycol 400 (UNII: B697894SGQ)  
    polyethylene glycol 3350 (UNII: G2M7P15E5P)  
    peppermint oil (UNII: AV092KU4JH)  
    saccharin sodium dihydrate (UNII: SB8ZUX40TY)  
    sorbic acid (UNII: X045WJ989B)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61010-8100-2 0.5 g in 1 PACKET
    2 NDC:61010-8100-1 144 in 1 BOX
    2 0.75 g in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 05/01/2010
    Labeler - Safetec of America, Inc. (874965262)
    Establishment
    Name Address ID/FEI Business Operations
    Safetec Of America, Inc. 874965262 MANUFACTURE(61010-8100)