Label: TETRACYTE TOPICAL TETRACYCLINE HYDROCHLORIDE- tetracycline hydrochloride ointment

  • NDC Code(s): 71262-009-01
  • Packager: VIADERMA DISTRIBUTION INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 1, 2024

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  • Drug Facts

  • Active Ingredient (in each gram)

    Tetracycline-HCl 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 if 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 clamis regarding stem cell healing are implied for this product
  • Other Information

    • Keep refrigerated
  • 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, water

  • Package Labelling:

    Outer Label.jpgInner Label.jpg

  • INGREDIENTS AND APPEARANCE
    TETRACYTE TOPICAL TETRACYCLINE HYDROCHLORIDE 
    tetracycline hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71262-009
    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)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBIC ACID (UNII: X045WJ989B)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71262-009-011 in 1 CARTON05/01/2024
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00405/01/2024
    Labeler - VIADERMA DISTRIBUTION INC (081113521)
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