Label: TERRASIL RAPID-CLEAR PSORIASIS- salicylic acid, thuja, sulfur kit

  • 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 April 18, 2014

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  • Active Ingredient

    Ointment: Salicylic Acid 3%
    Cleansing Bar: Thuja 3X HPUS, Sulfur 10X HPUS

    The letters HPUS indicate the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopeia of the United States

  • Purpose

    Salicylic Acid - Psoriasis and Seborrheic Dermatitis Treatment
    Thuja, Sulfur - Psoriasis Relief

  • Uses

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

  • Warnings

    For external use only

    Ask a doctor before use if you have psoriasis that covers a large area of the body.

    When using this product     avoid contact with the eyes. If contact occurs, rinse the eyes
    thoroughly with water.

    Stop use and ask a doctor if     condition worsens or does not improve after regular use as directed.

    Keep out of reach of children.

    If swallowed, consult a physician.

  • Directions

    Ointment: Spread thinly on affected areas 1-4 times daily or as directed by a doctor.
    Store at room temperature. May stain fabrics.
    Cleansing Bar: Wash affected area daily.

  • Inactive Ingredients

    Ointment: beeswax (organic), bentonite (volcanic clay), jojoba seed oil, magnesium oxide, peppermint oil, silver oxide, zinc oxide.

    Cleansing Bar: beeswax, bentonite clay, cedarwood oil, coconut oil, glycerin, jojoba seed oil, lauric acid, lavender oil, magnesium oxide, olive oil, palm acid, palm kernel acid, pentasodium pentetate, peppermint oil, propylene glycol, purified water, silver oxide, sodium stearate, sorbitol, shea butter, sodium laureth sulphate (SLES), stearic acid, sodium chloride, sodium palmate, sodium palm kernelate, sorbitol, titanium dioxide, tetrasodium etidronate, zinc oxide.

  • PRINCIPAL DISPLAY PANEL - BOX

    Psoriasis Therapy

    • Psoriasis and Seborrheic Dermatitis
    • Itching, Scaling and Redness
    • Helps Prevent Recurrence

    All Natural

    terrasil

    RAPID-CLEAR PSORIASIS OINTMENT

    Plus Medicated Cleansing Bar

    FIGHTS PSORIASIS SYMPTOMS

    THE END OF SUFFERING SKIN

    Healing and Relief Since 2004

    Box

  • INGREDIENTS AND APPEARANCE
    TERRASIL RAPID-CLEAR PSORIASIS 
    salicylic acid, thuja, sulfur kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-164
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-164-251 in 1 PACKAGE, COMBINATION
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 25 g
    Part 21 CARTON 75 g
    Part 1 of 2
    TERRASIL RAPID-CLEAR PSORIASIS 
    salicylic acid ointment
    Product Information
    Item Code (Source)NDC:24909-174
    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)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-174-2525 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H04/18/2014
    Part 2 of 2
    TERRASIL PSORIASIS MEDICATED CLEANSING BAR 
    thuja, sulfur soap
    Product Information
    Item Code (Source)NDC:24909-184
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG3 [hp_X]  in 1 g
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR10 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENTONITE (UNII: A3N5ZCN45C)  
    CEDAR LEAF OIL (UNII: BJ169U4NLG)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    JOJOBA OIL (UNII: 724GKU717M)  
    LAURIC ACID (UNII: 1160N9NU9U)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PALM ACID (UNII: B6G0Y5Z616)  
    PALM KERNEL ACID (UNII: 79P21R4317)  
    PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    SODIUM STEARATE (UNII: QU7E2XA9TG)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)  
    WATER (UNII: 059QF0KO0R)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-184-7575 g in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/18/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H04/18/2014
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-164) , label(24909-164)
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