VITASTEM (TETRACYCLINE HYDROCHLORIDE) OINTMENT [VIADERMA DISTRIBUTION, INC.]

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VITASTEM (TETRACYCLINE HYDROCHLORIDE) OINTMENT [VIADERMA DISTRIBUTION, INC.]
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NDC 71262-002-00, 71262-002-01, 71262-002-02, 71262-002-15
Set ID a6630858-7038-425f-8a75-bb25f36a0dbe
Category HUMAN OTC DRUG LABEL
Packager ViaDerma Distribution, Inc.
Generic Name
Product Class
Product Number
Application Number PART333B
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  • Drug Facts

  • Active Ingredient

    Tetracycline-HCI 30mg

    Purpose

    First Aid/Antibiotic

  • Indications:

    First aid to help prevent the risk of skin infection in minor cuts, scrapes, or burns

  • Warnings:

    For external 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 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.

    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.
  • 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.

  • Package Labeling:

    Label

  • VITASTEM-tetracycline hydrochloride ointment, 60 ml (71262-002-01)

    Label2

  • VITASTEM-tetracycline hydrochloride ointment, 100 ml (71262-002-02

    Label3Box

  • INGREDIENTS AND APPEARANCE
    VITASTEM 
    tetracycline hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71262-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TETRACYCLINE HYDROCHLORIDE (UNII: P6R62377KV) (TETRACYCLINE - UNII:F8VB5M810T) TETRACYCLINE HYDROCHLORIDE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71262-002-001 in 1 BOX02/09/2017
    15 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:71262-002-151 in 1 BOX07/01/2017
    215 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:71262-002-011 in 1 BOX11/08/2016
    360 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:71262-002-021 in 1 BOX11/08/2016
    4100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B11/08/2016
    Labeler - ViaDerma Distribution, Inc. (081113521)
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