Label: ABRASA- tetracycline hydrochloride spray

  • 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 16, 2021

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  • 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

    • In the eyes or apply over large areas of the body
    • Longer than 1 week unless directed by a doctor

    Ask a doctor before use if

    you have deep or puncture wounds, animal bites, or serious burns.

    Stop use and ask 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
    • Spray a small amount of this product on the area 1 to 3 time daily
    • May be covered with a sterile bandage
  • Other information

    • Stop use if product is misused: if the bottles is left open the liquid will tend to turn dark over time.
    • Contains no alcohol, no animal ingredients.
    • Blended for typical skin color.
    • May stain cloth.
  • Inactive ingredients

    Citric Acid, Dimethyl Sulfoxide, Fulvic Acid, Water, Zinc Oxide

  • Package Labeling:

    Bulk

  • INGREDIENTS AND APPEARANCE
    ABRASA 
    tetracycline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81489-001
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    FULVIC ACID (UNII: XII14C5FXV)  
    WATER (UNII: 059QF0KO0R)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81489-001-0129.5 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/30/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B01/30/2021
    Labeler - Azimuth Pharma, LLC (032996180)
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