Label: OPAHL- benzocaine gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/13

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Benzocaine, 20%

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  • Purpose

    Oral anesthetic

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  • Uses

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

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  • 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

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  • 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.

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  • 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.
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  • Other Information

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

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  • Inactive Ingredients

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

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  • Opahl

    Oral Anesthetic Gel Cherry Tart

    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: 53045-101-30 

    20131101 101 Benzocaine Cherry Tart

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  • INGREDIENTS AND APPEARANCE
    OPAHL 
    benzocaine gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53045-101
    Route of Administration ORAL, DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (BENZOCAINE) BENZOCAINE 6.4 g  in 32 g
    Inactive Ingredients
    Ingredient Name Strength
    FD&C RED NO. 40  
    POLYETHYLENE GLYCOL 3350  
    POLYETHYLENE GLYCOL 400  
    SACCHARIN SODIUM  
    .ALPHA.-TOCOPHEROL ACETATE  
    XYLITOL  
    WATER  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53045-101-30 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(53045-101)
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