Label: TERRASIL FISSURES FORMULA- cocoa butter 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 June 10, 2014

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  • Active Ingredient

    Cocoa Butter 50%

  • Purpose

    Skin Protectant

  • Uses

    For the temporary relief of local itching and discomfort in the perianal area, associated with anorectal disorders. Temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues. Temporarily protects irritated areas. Temporarily relieves burning.

  • Warnings

    For external and/or intrarectal use only. When using this product do not exceed the recommended daily dosage unless directed by a doctor. Stop use and ask a doctor if - bleeding occurs - condition worsens or does not improve within 7 days. If pregnant or breast-feeding, ask a health professional before use. 

    Keep out of reach of children.

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

  • Directions

    Adults: If practical, cleanse the affected area before use. Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement. Regular use provides continual therapy for relief of symptoms. Children under 12 years of age: ask a doctor.

  • Inactive Ingredients

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

  • PRINCIPAL DISPLAY PANEL - 14g Label

    terrasil with Activated Minerals

    Fissures Formula
    Coats. Soothes. Protects.

    Jar Label

  • INGREDIENTS AND APPEARANCE
    TERRASIL FISSURES FORMULA 
    cocoa butter ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-118
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER50 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENTONITE (UNII: A3N5ZCN45C)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CHAMOMILE (UNII: FGL3685T2X)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-118-1414 g in 1 JAR
    2NDC:24909-118-4444 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34606/10/2014
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-118) , label(24909-118)
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