Label: TETRACYCLINE-ABC- tetracycline hydrochloride ointment

  • NDC Code(s): 43074-115-01, 43074-115-02
  • 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 February 15, 2011

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.     
     

    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.  If not completely rubbed in after a 20-second rub-in, too much product was used.  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.  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


  • ACTIVE INGREDIENTS

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

  • 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.

  • 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.      
     

  • CHILDREN

     
    Keep away from children.      

  • PURPOSE


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

  • 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.   

  • 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.      
     

  • 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

  • DOSAGE & ADMINISTRATION


    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.  If not completely rubbed in after a 20-second rub-in, too much product was used.  Repeat the process three times daily.  For best results, refrigerate this product to reduce oxidation rate; to preserve effectiveness and color (normally orange).  Discard this product if color turns black.

  • USE


      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.      

  • 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, sodium bicarbonate.

  • Image of product

    Image of product

  • INGREDIENTS AND APPEARANCE
    TETRACYCLINE-ABC 
    tetracycline hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43074-115
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TETRACYCLINE HYDROCHLORIDE (UNII: P6R62377KV) (TETRACYCLINE - UNII:F8VB5M810T) TETRACYCLINE0.03 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    ascorbic acid (UNII: PQ6CK8PD0R)  
    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)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43074-115-021 in 1 BOTTLE, PLASTIC
    1NDC:43074-115-013 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B02/15/2011
    Labeler - Phillips Company (612368238)
    Establishment
    NameAddressID/FEIBusiness Operations
    Phillips Company612368238manufacture