Label: DERMACLINE- 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 November 8, 2016

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

  • Active Ingredient (in each gram)

    Tetracycline Hydrochloride 30mg

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  • Purpose

    First Aid antibiotic

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  • Use

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

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  • Warnings

    For esternam use only. May be harmful is swallowed.

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

    Do not use

    • In 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 trauma

    Stop use and ask a doctor if condition persists or gets worse.

    Keep our 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
    • 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.
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  • Other Information

    • Keep product refrigerated to preserve its effectiveness and color
    • Stop use if product is misused
    • 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.
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  • Inactive Ingredient

    Acetic Acid, Ascorbic Acid, chlorhexidine gluconate, cholecalciferol, dimethyl sulfoxide, dipropylene glycol, glucono delta lactone, GLYCERIN, histidine, hydroxethylc-cellulose, magnesium stearate, methylparaben, sodium hydroxide, sorbic acid, steric acid, water.

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  • Label- Dermacline Topical Ointment
  • INGREDIENTS AND APPEARANCE
    DERMACLINE 
    tetracycline hydrochloride ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:71250-002
    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
    ACETIC ACID (UNII: Q40Q9N063P)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HISTIDINE (UNII: 4QD397987E)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBIC ACID (UNII: X045WJ989B)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:71250-002-00 1 in 1 BOX 02/09/2017
    1 5 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 11/08/2016
    Labeler - Inventus, LLC (080506784)
    Establishment
    Name Address ID/FEI Business Operations
    Inventus, LLC 080506784 manufacture(71250-002)
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