Label: TETRASTEM- 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 25, 2014

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

  • Drug Facts
  • Active ingredient (in each gram)

    Tetracycline hydrochloride 30 mg

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  • Purpose

    First Aid Antibiotic

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  • Use

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

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  • 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 the 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 burns

    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.

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  • 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.
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  • Other information

    • Keep product refrigerated to preserve its effectiveness and color
    • Stop use if product is misused: If the bottle is left open and/or if not refrigerated, the liquid will tend to turn black over time. Discard the product if the liquid turns black due to misuse.
    • 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.
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  • Inactive ingredients

    ACETIC ACID, ASCORBIC ACID, CHLORHEXIDINE GLUCONATE,
    CHOLECALCIFEROL, DIMETHYL SULFOXIDE, DIPROPYLENE GLYCOL,
    GLUCONO DELTA LACTONE, GLYCERIN, HISTIDINE, HYDROXETHYLCELLULOSE,
    MAGNESIUM STEARATE, METHYLPARABEN, SODIUM
    HYDROXIDE, SORBIC ACID, STEARIC ACID, WATER

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  • Package Label

    TetraStem
    brand


    Refrigerate
    Topical
    Ointment


    First Aid
    Antibiotic
    Tetracycline
    Hydrochloride


    NET WT. 0.1 OZ (3 G)

    Patent Pending                           NDC 43074-301-11
    Alcohol free, no biological products
    www.PhillipsCompany.4T.com
    Phillips Company       Take it to the people
    Millerton, OK 74750 USA


    Remove top of plastic box to read full contents of the
    enclosed Drug Facts label. Plastic box top is not sealed.

    Side effects
    Same as other tetracycline products
    See listing of side effects online at
    www.PhillipsCompany.4T.com/CC.pdf
    Report any side effects to Phillips Company,
    311 Chickasaw Street, Millerton, OK 74750 USA
    Tel. 580-746-2430
    Email: hp@valliant.net TetraStem

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  • INGREDIENTS AND APPEARANCE
    TETRASTEM 
    tetracycline hydrochloride ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:43074-301
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TETRACYCLINE HYDROCHLORIDE (UNII: P6R62377KV) (TETRACYCLINE - UNII:F8VB5M810T) TETRACYCLINE HYDROCHLORIDE 30 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    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)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBIC ACID (UNII: X045WJ989B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43074-301-11 3 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 02/25/2014
    Labeler - Phillips Company (612368238)
    Establishment
    Name Address ID/FEI Business Operations
    Phillips Company 612368238 manufacture(43074-301)
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