Label: DIABECLINE- tetracycline hydrochloride ointment

  • 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 July 12, 2013

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

  • Diabecline Brand Topical Ointment First Aid Antibiotic Tetracycline Hydrochloride 0.1 OZ (3 G)

  • Active Ingredient (in each gram)


    Tetracycline hydrochloride 30 mg

  • Purpose

    Purpose
    First Aid Antibiotic

  • use

    First aid to help prevent skin infection in minor cuts, scrapes, and burns.



  • Warnings

    For external use only. May be harmful if swallowed.
    Allergy alert: Do not use if allergic to any ingredient listed on this label.


  • Do Not Use


    in the eyes.
    over large areas of the body.
    longer than 1 week unless directed by doctor.

  • Ask a doctor before use if you have

     deep or puncture wounds
     animal bites
     serious burns

  • Stop use and ask a doctor



      if condition persists or gets worse.

  • Keep Out of reach of children

    If swallowed, get medical help or contact a
    Poison Control Center right away.

  • 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 1 to 3 times daily. May be covered with a sterile bandage.

  • Other Information


    Keep product refrigerated to preserve its effectiveness and color.
    Stop use if product is misused: If the bottle is left open and/or if not refrigerated, the liquid will tend to turn black over time.
    Discard the product if the liquid turns black due to misuse.
    This product is an OTC antibiotic for human use.
    Contains no alcohol, no animal ingredients.
    Blended for typical skin color.
    May stain cloth.
    No claims regarding stem cell healing are implied for this product.

  • INACTIVE INGREDIENTS

    ASCORBIC ACID, CHLORHEXIDINE GLUCONATE, CHOLECALCIFEROL,
    DIMETHYL SULFOXIDE, DIPROPYLENE GLYCOL, GLUCONO DELTA
    LACTONE, GLYCERIN, HYDROXETHYLCELLULOSE, MAGNESIUM
    STEARATE, METHYLPARABEN, SODIUM HYDROXIDE, SORBIC ACID,
    STEARIC ACID, WATER

  • Diabecline Brand Topical Ointment First Aid Antibiotic Tetracycline Hydrochloride 0.1 OZ (3 G)

    DiabeclineTopicalOintmentLabel
  • INGREDIENTS AND APPEARANCE
    DIABECLINE 
    tetracycline hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43074-112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TETRACYCLINE HYDROCHLORIDE (UNII: P6R62377KV) (TETRACYCLINE - UNII:F8VB5M810T) TETRACYCLINE HYDROCHLORIDE30 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBIC ACID (UNII: X045WJ989B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43074-112-113 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B06/10/2013
    Labeler - Phillips Company (612368238)
    Establishment
    NameAddressID/FEIBusiness Operations
    Phillips Company612368238manufacture(43074-112)