Label: NATURASIL TINEA VERSICOLOR TREATMENT KIT- sulfur, thuja occidentalis kit

  • NDC Code(s): 10893-242-02
  • 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 14, 2024

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  • Naturasil Tinea Versicolor Relief Lotion

    Drug Facts

  • Active Ingredients:

    Sulfur 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 Versicolor Symptom Relief

  • Uses:

    Symptomatic treatment of Tinea Versicolor.

  • Warnings:

    For external use only.
    Ask a doctor before use if pregnant or nursing. Avoid using near eyes, mouth or mucous membranes.

    Keep out of reach of children. Do not use if tamper evident seal is broken. In case of ingestion, call Poison Control Center hotline immediately at 1-800-222-1222.

  • Directions:

    Shake well. Cleanse skin thoroughly with Tinea Versicolor Soap before applying lotion. Apply lotion 2-3 times per day to affected area until Tinea Versicolor has cleared. This two-part system does require you use both soap and lotion for proper healing. Re-Exposure to UV ray (the Sun) is essential in bringing back the melanin pigment of your skin. Some individuals may be sensitive to essential oils. Skin test for tolerability. If irritation or reaction occurs, discontinue use.

  • Inactive Ingredients:

    Aqua, Carbomer, Cetearyl Alcohol, Cymbopogon Citratus Leaf Oil, Eucalyptus Leaf Oil, Glyceryl Stearate, Helianthus Annus (Sunflower) Seed Oil, Jojoba Seed Oil, Lavender Oil, Melaleuca Alternifolia Leaf Oil, Patchouli Leaf Oil, Phenoxyethanol, Polysorbate 20, Potassium Sorbate, Sodium Hydroxide.

  • Naturasil Tinea Versicolor Relief Soap

    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 ray (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.

  • SPL UNCLASSIFIED SECTION

    Homeopathic Formula

    All Natural, Homeopathic, No Acids, Pain-Free for Children and Adults

    • Child-Safe (2 Yrs & Above)
    • 100% Natural Ingredients
    • 100% Pain-Free Solution

    #1 Selling Natural product Since 2003

    Now you can eradicate Tinea Versicolor at home with our Two-Part Tinea Versicolor Treatment Kit. We’ve included our highly effective 4 oz. Tinea Versicolor Lotion and our 4 oz. Tinea Versicolor Soap. Both our lotion and soap are made with 100% natural plant extracts. These powerful homeopathic formulas gently clear away Tinea Versicolor, a common fungal skin infection, without pain.

    Naturasil Tinea Versicolor Lotion is a natural blend of nourishing and anti-inflammatory essential oils that bring quick relief of Tinea Versicolor fungal infections. The added Sunflower oil helps to hydrate and soothe your skin.

    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 many common fungal skin infections including Tinea fungal infections. Each bar of soap is hand made, paraben free, EDTA free and Sodium Laurel Sulfate Free.

    Naturasil Tinea Versicolor Treatment Kit is recommended as a fast, natural solution that eliminates the need for an expensive dermatologist visit. Proudly small batched by our skilled production technicians in our FDA registered facility outside of Atlanta, Georgia USA.

    Lotion and soap MUST be used together for optimum relief and healing. Thoroughly wash affected area with Tinea Versicolor Relief Soap and dry. Next, apply Tinea Versicolor Lotion 2-3 times daily. Re-Exposure to UV rays (the 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.

    Questions? Comments?

    www.naturasil.com

    1-866-371-2499

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

    Not tested on animals.

    MADE IN USA

    *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

    KitKit componenets

  • INGREDIENTS AND APPEARANCE
    NATURASIL TINEA VERSICOLOR TREATMENT KIT 
    sulfur, thuja occidentalis kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10893-242
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10893-242-021 in 1 KIT; Type 0: Not a Combination Product03/12/2024
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 120 mL
    Part 21 PACKAGE 113.3 g
    Part 1 of 2
    NATURASIL TINEA VERSICOLOR RELIEF 
    sulfur lotion
    Product Information
    Item Code (Source)NDC:10893-241
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR6 [hp_X]  in 120 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    JOJOBA OIL (UNII: 724GKU717M)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    POGOSTEMON HEYNEANUS LEAF OIL (UNII: T9LWB48XAD)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/05/2024
    Part 2 of 2
    NATURASIL  TINEA VERSICOLOR
    sulfur-lavender soap
    Product Information
    Item 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
    1113.3 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/12/2024
    Labeler - Nature's Innovation, Inc. (602969854)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nature's Innovation, Inc.602969854manufacture(10893-242, 10893-241, 10893-620)
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