TANAC ORAL PAIN RELIEVER (BENZOCAINE) LIQUID [LEOSONS OVERSEAS CORP]

TANAC ORAL PAIN RELIEVER (BENZOCAINE) LIQUID [LEOSONS OVERSEAS CORP]
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NDC 69626-0049-4
Set ID 81cc61fa-31a7-2214-e053-2a91aa0ae46a
Category HUMAN OTC DRUG LABEL
Packager Leosons Overseas Corp
Generic Name
Product Class
Product Number
Application Number PART356
  • Drug Facts

  • Active Ingredients & Purposes

    Active IngredientPurpose
    Benzocaine 10%........................................................Oral pain reliever

  • Uses

    Temporarily relieves pain due to

    • canker sores
    • cold sores
    • fever blisters
    • minor irritations or injury of the mouth and gums
  • Warnings

    For oral use only.

    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
    medical 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.

    Flammability warning: Keep away from fire or flame.

    Stop use and ask a doctor or dentist if

    • sore mouth symptoms do not improve in 7 days
    • symptoms clear up and occur again within a few days
    • irritation, pain or redness persists or worsens swelling, rash, or fever develops

    If pregnant or breast-feeding,

    ask a health professional before use.

    Do not use

    • for teething
    • in children under 2 years of age

    When using this product

    • avoid contact with the eyes
    • do not use more than directed
    • do not use for more than 7 days unless directed by a dentist or doctor

    Keep out of reach of children.

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

  • Directions

    • apply product with cotton swab or clean fingertip to the affected area
    • adults and children 2 years of age and older: use up times 4 times daily or as directed by a

    dentist or doctor. Children should be supervised in the use of this product.

    • children under 2 years of age: do not use
  • Other information

    • store at 20 - 25°C (68 - 77°F)
    • do not use if imprinted safety seal is torn, broken or missing prior to opening
    • keep carton for full drug facts
  • Inactive ingredients

    benzalkonium chloride, peppermint oil, polyethylene glycol 400, propylene glycol, sodium saccharin, tannic acid

  • Questions?

    1-855-452-9500 or email at info@leosonsintl.com

  • Principal Display Panel

    • canker sores
    • gum irritations
    • cold sores
    • fever blisters

    Tanac ®

    Benzocaine 10%

    Oral Pain Reliever

    NO STING LIQUID

    0.45 FL Oz. (13.3mL)

    Tanac Box

  • INGREDIENTS AND APPEARANCE
    TANAC ORAL PAIN RELIEVER 
    benzocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69626-0049
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TANNIC ACID (UNII: 28F9E0DJY6)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69626-0049-41 in 1 CARTON01/01/2015
    113.3 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/01/2015
    Labeler - Leosons Overseas Corp (148605470)

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