Label: DYABETEX - tetracycline hydrochloride ointment

  • NDC Code(s): 43074-108-01, 43074-108-02
  • Packager: Phillips Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 September 5, 2010

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

  • DRUG FACTS

    DRUG FACTS
    Active Ingredient                           Purpose
    Tetracycline (3%) .......................  First-aid antibiotic

    Uses  
    First aid to help prevent skin infection in minor cuts, scrapes and burns
    For external use only.      
    Keep away from children.      
    Do not use in the eyes or apply over large areas of the body.       
    May be harmful if swallowed.       
    In case of deep or puncture wounds, animal bites, or serious burns, consult a physician.      
    Stop use and consult a physician if the condition persists or gets worse.       Do not use if allergic to any ingredient listed on this label.     
    Do not use longer than 1 week. 
    Discard this product 1 week after opening bottle.     

    Directions
    Clean the affected area.  Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area and rub gently using a cotton swab.    Repeat the process three times daily.  Keep this product refrigerated to preserve effectiveness and color.

    Other information    
    This product is an OTC antibiotic drug product for human use.  This product contains no alcohol; no animal ingredients; no biological ingredients. Blended for typical skin color.  May stain cloth.

    Inactive ingredients   
    Water, glycerin, hydroxethylcellulose, chlor-hexidine gluconate, glucono delta lactone, methylparaben, sodium hydroxide, dipropylene glycol, dimethyl sulfoxide, sorbic acid, ascorbic acid, magnesium stearate, stearic acid.  

    Side effects
    Same as other tetracycline products.  
    See listing of side effects online at
    www.PhillipsCompany.4T.com/CC.pdf
    Report any side effects to Phillips Company,
    311 Chickasaw Street, Millerton, OK USA 74750  
    Tel. 580-746-2430.
    Email:  PhillipsCompany@cox.net


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  • ACTIVE INGREDIENTS

    Active Ingredient                           Purpose
    Tetracycline (3%) .......................  First-aid antibiotic

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  • ASK DOCTOR

    ASK DOCTOR
       
      In case of deep or puncture wounds, animal bites, or serious burns, consult a physician.      
      Stop use and consult a physician if the condition persists or gets worse.

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  • DO NOT USE


      For external use only.      
      Keep away from children.      
      Do not use in the eyes or apply over large areas of the body.       
      May be harmful if swallowed.       
      Do not use if allergic to any ingredient listed on this label.      
      Do not use longer than 1 week.  Discard this product 1 week after opening bottle.     

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  • CHILDREN

     
    Keep away from children.      
    Discard this product 1 week after opening bottle.    

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  • PURPOSE


    Active Ingredient                           Purpose
    Tetracycline (3%) .......................  First-aid antibiotic

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  • STOP USE

    Stop use and consult a physician if the condition persists or gets worse.       

    Do not use if allergic to any ingredient listed on this label.   

    Do not use longer than 1 week.  Discard this product 1 week after opening bottle.    

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  • WHEN USING


      First aid to help prevent skin infection in minor cuts, scrapes and burns
      
      In case of deep or puncture wounds, animal bites, or serious burns, consult a physician.      
     

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  • WARNINGS

    Side effects:  same as other tetracycline products.  
    See listing of side effects online at www.PhillipsCompany.4T.com/CC.pdf
    Report any side effects to Phillips Company, 311 Chickasaw Street, Millerton, OK USA 74750  
    Tel. 580-746-2430.  Email:  PhillipsCompany@cox.net

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  • DOSAGE & ADMINISTRATION

    Directions
    Clean the affected area.  Apply 2 drops of this liquid on the affected area about the size of a nickel or dime, and rub gently using a cotton swab.    For international users, a nickel or a dime is approximately 1.5 square centimeters.  Repeat the process three times daily.  Keep this product refrigerated to preserve effectiveness and color. Close
  • USE

    Uses  
      First aid to help prevent skin infection in minor cuts, scrapes and burns
      For external use only.      
      Keep away from children.      
      Do not use in the eyes or apply over large areas of the body.       
      May be harmful if swallowed.       
      In case of deep or puncture wounds, animal bites, or serious burns, consult a physician.      
      Stop use and consult a physician if the condition persists or gets worse.        Do not use if allergic to any ingredient listed on this label.      
      Do not use longer than 1 week.  Discard this product 1 week after opening bottle.

    Close
  • INACTIVE INGREDIENTS

    Water, glycerin, hydroxethylcellulose, chlorhexidine gluconate, glucono delta lactone, methylparaben, sodium hydroxide, dipropylene glycol, dimethyl sulfoxide, sorbic acid, ascorbic acid, magnesium stearate, stearic acid.

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  • Image of product

    Image of product

    Image of product

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  • INGREDIENTS AND APPEARANCE
    DYABETEX 
    tetracycline hydrochloride ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:43074-108
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TETRACYCLINE HYDROCHLORIDE (UNII: P6R62377KV) (TETRACYCLINE - UNII:F8VB5M810T) TETRACYCLINE 0.03 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    dipropylene glycol (UNII: E107L85C40)  
    Water (UNII: 059QF0KO0R)  
    glycerin (UNII: PDC6A3C0OX)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    calcium gluconate (UNII: SQE6VB453K)  
    methylparaben (UNII: A2I8C7HI9T)  
    sodium hydroxide (UNII: 55X04QC32I)  
    sorbic acid (UNII: X045WJ989B)  
    magnesium stearate (UNII: 70097M6I30)  
    stearic acid (UNII: 4ELV7Z65AP)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43074-108-02 1 in 1 BOTTLE, PLASTIC
    1 NDC:43074-108-01 3 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 08/24/2010
    Labeler - Phillips Company (612368238)
    Establishment
    Name Address ID/FEI Business Operations
    Phillips Company 612368238 manufacture
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