Label: NATURASIL TINEA VERSICOLOR- sulfur-lavender soap

  • NDC Code(s): 10893-620-04, 10893-620-45
  • Packager: Nature's Innovation, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated March 12, 2024

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  • Drug Facts

  • Active Ingredients:

    Sulfur 1X HPUS
    Thuja Occidentalis 6X HPUS.

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

  • Purpose:

    Tinea Fungus Symptom Relief.

  • Uses:

    Symptomatic homeopathic topical treatment of common fungal tinea versicolor.

  • Warnings:

    For external use only. Ask a doctor before use if pregnant or nursing. Avoid using near eyes, mouth or mucous membranes. If contact with eyes or mucous membranes occurs, rinse thoroughly with water.

    Keep out of reach of children. In case of ingestion, call Poison Control Center hotline immediately at 1-800-222-1222

  • Directions:

    Use soap at least 2 times per day, for 4-10 days. Re-Exposure to UV rays (Sun) is essential in bringing back the melanin pigment of your skin. Drying of skin may occur. Some individuals may be sensitive to essential oils. Skin test for tolerability. If irritation or reaction occurs, discontinue use.

  • Inactive Ingredients:

    Aqua, Citric Acid, Cocamidopropyl Betaine, Cocos Nucifera (coconut oil), Glycerin, Glyceryl Laurate, Lavender Oil, Pentasodium Pentetate, Propylene Glycol, Sodium Chloride, Sodium Citrate, Sodium Laurate, Sodium Myristate, Sodium Oleate, Sodium Stearate, Sodium Thiosulfate, Sorbitol, Tetrasodium Etidronate, Titanium Dioxide, Trisodium Sulfosuccinate.

  • Questions? Comments?

    (866)371-2499    www.naturasil.com

    Mfd. by: Nature's Innovation, Inc.
    5317 Palmero Court, Buford, GA 30518

    Made in the U.S.A. 

  • SPL UNCLASSIFIED SECTION

    Homeopathic Formula

    Made with Sulfur, Pure Lavender Oil, & Natural Plant Extracts

    Paraben Free   EDTA Free   SLS Free

    Naturasil Tinea Versicolor Sulfur-Lavender Homeopathic Soap is a micronized volcanic sulfur soap with pure lavender oil and natural plant extracts. Due to their naturally occurring and proven calming properties, sulfur and lavender have been used for centuries in assisting in the treatment of common fungal skin infections such as tinea fungal infections (Tinea Versicolor). Each bar of soap is hand made, paraben free, EDTA free and Sodium Laurel Sulfate Free.

    Not Tested on Animals.

    *These statements or claims are based upon traditional homeopathic practice. They have not been reviewed by the Food & Drug Administration. “X “is a homeopathic dilution: see www.naturasil.com/homeopathy for details,” depending on the dilutions used in the product.

  • Packaging

    Naturasil Soap

  • INGREDIENTS AND APPEARANCE
    NATURASIL  TINEA VERSICOLOR
    sulfur-lavender soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10893-620
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR1 [hp_X]  in 1 g
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG6 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SODIUM LAURATE (UNII: K146MR5EXO)  
    SODIUM MYRISTATE (UNII: 06BLC4V0IV)  
    SODIUM OLEATE (UNII: 399SL044HN)  
    SODIUM STEARATE (UNII: QU7E2XA9TG)  
    SODIUM THIOSULFATE (UNII: HX1032V43M)  
    SORBITOL (UNII: 506T60A25R)  
    ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRISODIUM SULFOSUCCINATE (UNII: 085WB9L09N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10893-620-45127.6 g in 1 BOX; Type 0: Not a Combination Product01/01/201201/01/2019
    2NDC:10893-620-04113.3 g in 1 PACKAGE; Type 0: Not a Combination Product01/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/2012
    Labeler - Nature's Innovation, Inc. (602969854)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nature's Innovation, Inc.602969854manufacture(10893-620)
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