Label: SCARGUARD MD PHYSICIANS FORMULA- hydrocortisone silicone liquid

  • Category: HUMAN OTC DRUG LABEL

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 10, 2010

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  • Active Ingredients

    Silicone 12.75%
    Hydrocortisone 0.55%

  • Purpose

    Scar Management

    Anti-Pruritic

  • Uses

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

    For external use only

  • Do not use

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

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

    • condition worsens
    • symptoms persist for more than 7 days
  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • 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
  • Other Information

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

  • Inactive Ingredients

    vitamin E, specially-formulated flexible collodion

  • Questions?

    call 1-877-566-5935

  • Carton 30mL

    30 mL carton

  • INGREDIENTS AND APPEARANCE
    SCARGUARD MD PHYSICIANS FORMULA 
    hydrocortisone silicone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64269-9909
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE5.5 mg  in 1 mL
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) (PHENYL TRIMETHICONE - UNII:DR0K5NOJ4R) PHENYL TRIMETHICONE12.75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    PYROXYLIN (UNII: KYR8BR2X6O)  
    ETHER (UNII: 0F5N573A2Y)  
    ALCOHOL (UNII: 3K9958V90M)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64269-9909-230 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/01/2001
    Labeler - Scarguard Labs, LLC (842204575)
    Registrant - Scarguard Labs, LLC (842204575)
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