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Opahl (Dharma Research, inc.)

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GEL 32 g in 1 BOTTLE (53045-100-30) Label Information

Complete Opahl Information

  • Active Ingredient

    Benzocaine, 20%


  • Purpose

    Oral anesthetic


  • Uses

    For the temporary relief of pain associated with canker sores and minor dental procedures


  • Warnings

    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.

    Do not use

    this product 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, or fever develops, see your dentist or doctor promptly.

    Do not

    exceed recommended dosage


  • Keep out of reach of children

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


  • Directions

    • Adults and children 2 years of age and older:  Apply to the affected area.  Use up to 4 times daily or as directed by a dentist or doctor.
    • Children under 12 years of age should be supervised in the use of this product
    • Children under 2 years of age: Consult a dentist or doctor.

  • Other Information

    Store at room temperature 59-86°F (15-30°C). Protect from freezing and heat.


  • Inactive Ingredients

    FD&C Red #40, Flavor, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharine sodium, Tocopheryl acetate, Xylitol, Water


  • Opahl

    Oral Anesthetic Gel Bubble Gum

    with Vitamin E and Xylitol

    Gluten Free

    1.12 oz (32 g)

    Manufactured by Dharma Research, Inc., 5220 NW 72nd Ave, Unit 15, Miami, FL 33166

    1-877-833-3725

    www.dharmaresearch.com

    NDC: 53045-100-30

    20131101 100 Benzocaine Bubble Gum


  • INGREDIENTS AND APPEARANCE
    OPAHL 
    benzocaine gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:53045-100
    Route of Administration ORAL, DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 6.4 g  in 32 g
    Inactive Ingredients
    Ingredient Name Strength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XYLITOL (UNII: VCQ006KQ1E)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor BUBBLE GUM Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53045-100-30 32 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 11/02/2013
    Labeler - Dharma Research, Inc. (078444642)
    Registrant - Dharma Research, Inc. (078444642)
    Establishment
    Name Address ID/FEI Business Operations
    Dharma Research, Inc. 078444642 manufacture(53045-100)