Label: VITASTEM- tetracycline hydrochloride ointment

  • NDC Code(s): 71262-002-00, 71262-002-01, 71262-002-02, 71262-002-15
  • Packager: ViaDerma Distribution, 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 March 27, 2019

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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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