Label: VIABECLINE FIRST AID ANTIBIOTIC- tetracycline hydrochloride ointment

  • NDC Code(s): 69006-005-00, 69006-005-01
  • Packager: VIADERMA II, INC.
  • 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 December 23, 2017

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  • Drug Facts
  • Active ingredient (in each gram)

    Tetracycline hydrochloride 30 mg

    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 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.

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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 pressrve 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.
    • Containa 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 ingredients

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

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  • Package Labeling:
  • INGREDIENTS AND APPEARANCE
    VIABECLINE FIRST AID ANTIBIOTIC 
    tetracycline hydrochloride ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69006-005
    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)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HISTIDINE (UNII: 4QD397987E)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBIC ACID (UNII: X045WJ989B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69006-005-00 1 in 1 BOX 05/13/2017
    1 15 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:69006-005-01 28 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/13/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 05/13/2017
    Labeler - VIADERMA II, INC. (079387584)
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