Label: DIABECLINE - tetracycline hydrochloride ointment

  • NDC Code(s): 24471-200-10, 24471-200-30
  • Packager: THRU PHARMA, LLC
  • 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 May 23, 2013

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

  • Active ingredient

    Tetracycline hydrochloride 3%

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  • Purpose

    First aid antibiotic ointment

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  • Uses

    first aid to help prevent infection in minor:

    • cuts
    • scrapes
    • burns
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  • Warnings

    For external use only

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  • Do not use

    • if you are allergic to any of the ingredients
    • in the eyes
    • over large areas of the body
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  • Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns
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  • Stop use and ask a doctor if

    • you need to use longer than 1 week
    • condition persists or gets worse
    • rash or other allergic reaction develops
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  • Keep out of reach of children.

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

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  • Directions

    • clean the affected area
    • hold the tube gently, with swab handle facing upward, pinch tube firmly at dotted line.  With other hand, grasp applicator handle at base.

    • bend gently down until seal is broken, twist gently until handle separates from tube

    • use EasySnap™ handle to pull swab from tube

    • 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

    • discard swab applicator after use

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  • Other information

    • tamper evident:  safety sealed swabs.  Do not use if seal has been broken.
    • store at room temperature 20-25°C (68-77°F)
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  • Inactive ingredients

    ascorbic acid (vitamin C), cholecalciferol (vitamin D3), dimethyl sulfoxide, dipropylene glycol

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  • Questions?

    Call 1-888-396-5139

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  • Principal display panel

    NEW!  NDC 24471-200-10

    Diabecline®

    Tetracycline HCl 3% | First Aid Antibiotic Ointment

    The Power to Protect. 

    Maximum Strength
    First Aid Antibiotic Ointment
     


    24 Hour Infection Protection
     

    10 EasySnap™ Swabs
    0.2 ml each

    Maximum strength hypoallergenic topical first aid antibiotic


    Broad-spectrum dual-action antibiotic kills bacteria, creates a zone of protection


    Convenient EasySnap™ swab application for extra reach and precise delivery


    Questions? Visit diabecline.com or call 1-888-396-5139


    100% MONEY BACK GUARANTEE


    PharmaCline

    Diabecline Carton

    Diabecline®

    Tetracycline HCl 3% | First Aid Antibiotic Ointment

    100% MONEY BACK GUARANTEE

    Diabecline Drug Facts

    Diabecline®

    Tetracycline HCl 3% | First Aid Antibiotic Ointment

    with Vitamin D

    1 EasySnap™ Swab 0.2 ml


    See package insert for full product Uses, Directions and Warnings.


    Store at 20-25°C (68-77°F)

    Tamper evident: do not use if cap on swab is broken or missing

    Dist. by: pharmaCline, Sioux Falls, SD 57107

    ©pharmaCline 2012   1-888-396-5139

    PINCH HERE, SNAP & PULL OUT

    Diabecline Swab Label
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  • INGREDIENTS AND APPEARANCE
    DIABECLINE  
    tetracycline hydrochloride ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:24471-200
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Tetracycline Hydrochloride (UNII: P6R62377KV) (Tetracycline - UNII:F8VB5M810T) Tetracycline Hydrochloride 30 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Ascorbic Acid (UNII: PQ6CK8PD0R)  
    Cholecalciferol (UNII: 1C6V77QF41)  
    Dimethyl Sulfoxide (UNII: YOW8V9698H)  
    Dipropylene Glycol (UNII: E107L85C40)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24471-200-10 10 in 1 BOX
    1 .2 mL in 1 APPLICATOR
    2 NDC:24471-200-30 30 in 1 BOX
    2 .2 mL in 1 APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 05/23/2013
    Labeler - THRU PHARMA, LLC (968309232)
    Establishment
    Name Address ID/FEI Business Operations
    Great Midwest Packaging, LLC 784514502 REPACK(24471-200)
    Establishment
    Name Address ID/FEI Business Operations
    Continental Manufacturing Chemist, Inc. 005278007 MANUFACTURE(24471-200)
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