Label: SCARGUARD MD PHYSICIANS FORMULA - hydrocortisone and phenyl trimethicone liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 06/10

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

  • Active Ingredients

    Silicone 12.75%
    Hydrocortisone 0.55%

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  • Purpose

    Scar Management

    Anti-Pruritic

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  • Uses

    • scar management
    • for the temporary relief of itching associated with minor skin irritations, inflammation and rashes
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  • Warnings

    For external use only

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  • Do not use

    • on children under 2 years of age. Consult a doctor.
    • on mucous membranes
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  • When using this product

    • avoid contact with the eyes
    • use in a well ventilated area
    • flammable until dry
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  • Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days
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  • 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 affected area with mild soap and water, dry thoroughly
    • brush on twice daily
    • allow to dry for 1 minute before coming into contact with clothing
    • reapply if peeling
    • children from 2-12 years of age ask a doctor
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  • Other Information

    • store at 15º to 30º C (59º to 86ºF)
    • Keep bottle tightly closed or product will evaporate

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  • Inactive Ingredients

    vitamin E, specially-formulated flexible collodion

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  • Questions?

    call 1-877-566-5935

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  • Carton 30mL
  • INGREDIENTS AND APPEARANCE
    SCARGUARD MD PHYSICIANS FORMULA 
    hydrocortisone silicone liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:64269-9909
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 5.5 mg  in 1 mL
    PHENYL TRIMETHICONE (PHENYL TRIMETHICONE) PHENYL TRIMETHICONE 12.75 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALPHA-TOCOPHEROL  
    PYROXYLIN  
    ETHER  
    ALCOHOL  
    CAMPHOR (SYNTHETIC)  
    CASTOR OIL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64269-9909-2 30 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 10/01/2001
    Labeler - Scarguard Labs, LLC (842204575)
    Registrant - Scarguard Labs, LLC (842204575)
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