Label: TETRANEXT- tetracycline hydrochloride ointment

  • 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 February 3, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Tetracycline hydrochloride 3%

  • Purpose

    First aid antibiotic ointment

  • Uses

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

  • Warnings

    For external use only

    Do not use

    • in the eyes
    • if you are allergic to any of the ingredients
    • over large areas of the body
    • Longer than 1 week unless directed by a physician

    Ask a physician before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    Stop use and ask a physician if

    • condition persists or gets worse
    • rash or other allergic reaction occurs

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Clean the infected area
    • Remove the twist cap from one vial
    • Apply a small amount of this product (an amount equal to the surface area of the finger) on the area 1 to 3 times daily, or as directed by a physician
    • Discard vial after use
    • May be covered with a sterile bandage
  • Other Information

    • Store at room temperature 20-25°C (68-77°F)
  • Inactive Ingredients

    Water, glycerin, hydroxethylcellulose, chlor-hexide gluconate, glucono delta lactone, methylparaben, sodium hydroxide, dipropylene glycol, dimethyl sulfoxide, sorbic acid, ascorbic acid, magnesium stearate, stearic acid

  • Questions or comments?

    Call 1-866-957-2938

  • PRINCIPAL DISPLAY PANEL - 0.3 mL Vial Carton

    SAXET | PHARMACEUTICALS

    TetraNext™

    Tetracycline HCl 3% | First Aid Ointment

    MAXIMUM INFECTION PROTECTION

    20 single-use vials - 0.3 mL each
    NDC 70598-001-20

    PRINCIPAL DISPLAY PANEL - 0.3 mL Vial Carton
  • INGREDIENTS AND APPEARANCE
    TETRANEXT 
    tetracycline hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70598-001
    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
    Water (UNII: 059QF0KO0R)  
    glycerin (UNII: PDC6A3C0OX)  
    hydroxymethyl cellulose (UNII: 273FM27VK1)  
    chlorhexidine gluconate (UNII: MOR84MUD8E)  
    gluconolactone (UNII: WQ29KQ9POT)  
    methylparaben (UNII: A2I8C7HI9T)  
    sodium hydroxide (UNII: 55X04QC32I)  
    dipropylene glycol (UNII: E107L85C40)  
    dimethyl sulfoxide (UNII: YOW8V9698H)  
    sorbic acid (UNII: X045WJ989B)  
    ascorbic acid (UNII: PQ6CK8PD0R)  
    magnesium stearate (UNII: 70097M6I30)  
    stearic acid (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorBROWN (Light brown) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70598-001-2020 in 1 CARTON08/01/2016
    10.3 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:70598-001-055 in 1 CARTON08/01/2016
    20.3 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333B08/01/2016
    Labeler - Saxet Pharmaceuticals (080032028)
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