1. Home
  2. Labeler Index
  3. Budpak Inc.
  4. 27293-012
  5. Label Information: Oral Gel Maximum Strength

FDA Label for Oral Gel Maximum Strength

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - WHEN USING
    6. OTC - STOP USE
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DOSAGE & ADMINISTRATION
    9. OTHER
    10. INACTIVE INGREDIENT
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Oral Gel Maximum Strength Product Label

The following document was submitted to the FDA by the labeler of this product Budpak Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active IngredientBenzocaine 20%

Otc - Purpose



PurposeAnesthetic

Indications & Usage



Uses for the temporary relief of pain associated with:
  • toothache  
  • canker sores  
  • cold sores  
  • fever blisters  
  • minor dental procedures

Warnings



Warnings
  • do not use for more than 7 days unless directed by a dentist or a doctor
  • if you have a history of allergy to local anesthetics such as procaine, butacaine or other "caine" anesthetics

Otc - When Using



When using this product
  • avoid contact with the eyes  
  • do not exceed recommended dosage

Otc - Stop Use



Stop using and ask a doctor
  • sore mouth symptoms do not improve in 7 days
  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens

Otc - Keep Out Of Reach Of Children



Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Dosage & Administration



Directions adults and children 2 years of age and older:
  • cut open tip of tube
  • apply to the affected area 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 the product
  • children under 2 years of age, there is no recommended dosage except under the advice and supervision of a dentist or a doctor

Other



Other information
  • store at room temperature
  • Lot No. and Exp. Date: see box or see crimp of tube

Inactive Ingredient



Inactive Ingredients Purified water, Glycerin, Propylene Glycol, Hydroxyethylcellulose, Carbomer, Sorbic Acid, Methylparaben, Propylparaben, FDC Yellow 5, FDC Red 40

Package Label.Principal Display Panel



Package Label

* Please review the disclaimer below.