Label: TERRASIL PSORIASIS THERAPY MAXIMUM STRENGTH- salicylic acid ointment

  • 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 December 29, 2018

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active Ingredients

    Salicylic Acid 3%

  • Purpose

    Psoriasis and Seborrheic Dermatitis Treatment

  • Uses

    Relieves and helps prevent recurrence of skin: - irritation, - itching, - redness, - flaking, - scaling due to psoriasis and seborrheic dermatitis

  • KEEP OUT OF REACH OF CHILDREN

  • Warnings

    For external use only.

  • Directions

    Apply to affected areas one to four times daily or as directed by a doctor. Store at room temperature.

  • Inactive Ingredients

    beeswax (organic), bentonite (volcanic clay), cotton seed oil, jojoba seed oil, magnesium oxide, peppermint oil, silver oxide, stearic acid (naturally sourced), zinc oxide.

  • PRINCIPAL DISPLAY PANEL - 50g Tube

    All Natural
    terrasil®
    PSORIASIS THERAPY
    MAXIMUM STRENGTH
    with Activated Minerals®

    Terrasil

  • INGREDIENTS AND APPEARANCE
    TERRASIL PSORIASIS THERAPY  MAXIMUM STRENGTH
    salicylic acid ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-134
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENTONITE (UNII: A3N5ZCN45C)  
    COTTONSEED OIL (UNII: H3E878020N)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-134-1414 g in 1 JAR; Type 0: Not a Combination Product12/12/2012
    2NDC:24909-134-4444 g in 1 JAR; Type 0: Not a Combination Product12/12/2012
    3NDC:24909-134-1514 g in 1 TUBE; Type 0: Not a Combination Product12/29/2018
    4NDC:24909-134-5050 g in 1 TUBE; Type 0: Not a Combination Product12/29/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H12/12/2012
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-134) , label(24909-134)