Label: DENTAL RELIEF- benzocaine liquid

  • NDC Code(s): 68421-8100-2, 68421-8100-3, 68421-8100-4
  • Packager: Cintas First Aid & Safety
  • 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 February 27, 2014

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  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:68421-8100
    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 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:68421-8100-310 in 1 BAG05/06/2016
    1NDC:68421-8100-20.5 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:68421-8100-4500 in 1 BOX05/06/2016
    2NDC:68421-8100-20.5 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 finalpart35605/06/2016
    Labeler - Cintas First Aid & Safety (056481716)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec Of America, Inc.874965262MANUFACTURE(68421-8100)
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