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Dental Relief (Cintas First Aid & Safety)

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LIQUID .5 g in 1 PACKET (68421-8100-2) Label Information

Complete Dental Relief Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Dental Relief


  • Active Ingredients

    Benzocaine 20% (w/w)


  • Purpose

    Oral antiseptic


  • Uses

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


  • Warnings

    For oral use only

    Allergy alert

    Do not use this product if you have a history of allergy to local anaesthetics, such as procaine, butacaine, benzocaine, or other “caine” anaesthetics 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 and protection 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 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, 15° to 30°C (59° to 86°F)
    • Avoid contact with eyes

  • Inactive Ingredients

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


  • Principal Display Panel – 0.5 gram Packet

    Dental Relief

    Active ingredients: Benzocaine (20%), Compound benzoin tincture

    USES: Temporarily relieves pain due to canker sores, minor irritation of
    the mouth and gums caused by dentures or orthodontic appliances,
    or minor mouth and gum injuries.

    Do not use if packet is torn or broken

    NET WT 0.5g

    Principal Display Panel – 0.5 gram Packet

  • Principal Display Panel – Pocket Card

    Dental Relief

    PROFESSIONAL STRENGTH
    RELIEVES DENTAL PAIN

    COMPARE TO ORAJEL

    SEE DRUG FACTS CARD
    FOR COMPLETE WARNINGS

    560718
    12/13

    Xpect
    First aid

    Principal Display Panel – Pocket Card

  • INGREDIENTS AND APPEARANCE
    DENTAL RELIEF 
    benzocaine liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68421-8100
    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 (UNII: SB8ZUX40TY)  
    sorbic acid (UNII: X045WJ989B)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68421-8100-3 10 in 1 BAG 05/06/2016
    1 NDC:68421-8100-2 0.5 g in 1 PACKET; Type 0: Not a Combination Product
    2 NDC:68421-8100-4 500 in 1 BOX 05/06/2016
    2 NDC:68421-8100-2 0.5 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 05/06/2016
    Labeler - Cintas First Aid & Safety (056481716)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    Name Address ID/FEI Business Operations
    Safetec Of America, Inc. 874965262 MANUFACTURE(68421-8100)