Label: TETRACYTE TOPICAL TETRACYCLINE HYDROCHLORIDE- 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 June 21, 2022

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

  • 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 day

    • longer than 1 week unless directed by doctor

    Ask a doctor before use if you have

    • deep or puncture wounds • animal bites • serous 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

  • Other Information

    • For best results refrigerate or store in a cool dark place.

  • Inactive Ingredinets

    acetic acid, ascorbic acid, chlorhexidine gluconate, cholecalciferol, dimethyl sulfoxide, propanediol, glucono delta lactone, glycerin, histidine, hydroxyethyl cellulose, magnesium stearate, sodium hydroxide, sorbic acid, stearic acid, water

  • Package Labeling: TETRACYTE TOPICAL - tetracycline hydrochloride ointment, 15ml (82776-000-15)

    Label

  • INGREDIENTS AND APPEARANCE
    TETRACYTE TOPICAL TETRACYCLINE HYDROCHLORIDE 
    tetracycline hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82776-000
    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)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HISTIDINE (UNII: 4QD397987E)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBIC ACID (UNII: X045WJ989B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82776-000-151 in 1 BOX06/01/2022
    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 finalpart333B06/01/2022
    Labeler - THE WOUND DOCS, LLC (118705435)