Label: TERRASIL BOIL PAIN RELIEF- benzocaine ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 June 20, 2014

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  • Active Ingredient

    Benzocaine 3.5%

  • Purpose

    Pain Reliever

  • Uses

    For the temporary relief of pain and discomfort caused by boils.

  • Warnings

    For external use only. Do not use for more than 3 days. Ask a doctor before use if you have boils on the lips, nose, cheeks, or forehead. When using this product avoid contact with the eyes. Stop use and ask a doctor if - fever occurs, - redness around the boil develops, - condition worsens or does not improve, - symptoms persist for more than 3 days, - symptoms clear up and occur again within a few days.

    Keep out of reach of children.

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

  • Directions

    Adults and children 2 years of age and older: Apply to affected area no more than 2 times daily. Children under 2 years of age: Consult a doctor. Store at room temperature. May stain fabrics.

  • Inactive Ingredients

    beeswax (organic), bentonite (volcanic clay), jojoba seed oil, magnesium oxide, silver oxide, tea tree oil, turmeric, zinc oxide.

  • PRINCIPAL DISPLAY PANEL - 44g Label

    terrasil with Activated Minerals

    Boil Pain Relief
    Fast. Powerful. Relief.

    Jar Label

  • INGREDIENTS AND APPEARANCE
    TERRASIL BOIL PAIN RELIEF 
    benzocaine ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE3.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENTONITE (UNII: A3N5ZCN45C)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    TURMERIC (UNII: 856YO1Z64F)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-120-1414 g in 1 JAR
    2NDC:24909-120-4444 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/20/2014
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-120) , label(24909-120)
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