Label: TETRACYCLINE 3 PERCENT A FIRST AID ANTIBIOTIC- tetracycline hydrochloride ointment

  • NDC Code(s): 72053-000-00
  • Packager: Patient Focused Tele-Health, 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 April 13, 2018

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

  • Drug Facts

  • Active ingredient (in each gram)

    Tetracycline Hydrochloride 30 mg

    Purpose

    First Aid Antibiotic

  • Use

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

  • Warnings

    For external use only.

    Do not use

    • longer than 1 week unless directed by a doctor
    • in the eyes
    • over large areas of the body

    Ask a doctor before use if you have

    deep or puncture wounds, animal bites, or 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

  • 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.
  • Inactive ingredients

    Ascorbic Acid, Cholecalciferol, Diazolidinyl Urea*, Dimethyl Sulfoxide, Dipropylene Glycol, Glucono Delta Lactone*, Glycerin, Polysorbate 80*, Propylene Glycol*, Sodium Hydroxide, Water *Contains one or more of these ingredients

  • Package Labeling:

    Outer PackageInner Package

  • INGREDIENTS AND APPEARANCE
    TETRACYCLINE 3 PERCENT A FIRST AID ANTIBIOTIC 
    tetracycline hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72053-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TETRACYCLINE HYDROCHLORIDE (UNII: P6R62377KV) (TETRACYCLINE - UNII:F8VB5M810T) TETRACYCLINE HYDROCHLORIDE30 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72053-000-001 in 1 BOX04/01/2018
    13 g in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B04/01/2018
    Labeler - Patient Focused Tele-Health, LLC (081008911)