Label: ANISTEM- tetracycline hydrochloride spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2024

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

View All Sections
  • 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.

    AllergyAlert

    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 claims regarding stem cell healing are implied for this product



  • Other Information

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

  • Inactive Ingredients

    acetic acid, ascorbic acid, chlorhexidine gluconate, cholecalciferol, dimethyl sulfoxide, dipropylene glycol, glucono delta lactone, glycerin, histidine, hydroxethyl-cellulose, magnesium stearate, sodium hydroxide, sorbic acid, stearic acid, water

  • PRINCIPAL DISPLAY PANEL

    BottleBottle2Bottle3

  • INGREDIENTS AND APPEARANCE
    ANISTEM 
    tetracycline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79218-000
    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)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    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:79218-000-011 in 1 BOX07/01/202012/09/2024
    155 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00407/01/202012/09/2024
    Labeler - MATRIX MIXOLOGY, INC (128885636)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!