Label: NATURASIL SCABIES- sulfur cream

  • NDC Code(s): 10893-083-12
  • 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 October 1, 2011

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Drug Facts

    Active Ingredients


    Sulfur 1X HPUS

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


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  • PURPOSE


    Purpose

    Scabies Symptom Relief


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  • INDICATIONS & USAGE

    Uses: Symptomatic treatment of scabies.

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  • WARNINGS

    Warnings: For external use only.

    Ask a doctor before use if pregnant or nursing.

    Avoid using near eyes, mouth or mucous membranes. If eye contact occurs, rinse thoroughly with water and consult a doctor.

    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.

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  • DOSAGE & ADMINISTRATION

    Directions: Cleanse skin thoroughly before applying. Cover the affected skin with cream one time per day. If excessive drying of the skin or rash occurs, reduce the application of product or discontinue use. To speed relief, we recommend using Naturasil Sulfur Lavender Soap. Some individuals may be sensitive to sulfur or essential oils. Skin test for tolerability. If irritation or reaction occurs, discontinue use.

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  • INACTIVE INGREDIENT

    Inactive Ingredients:  Butyrospermum Parkii (Shea Butter) Fruit, Calendula (Calendula Officinalis) Oil, Cetyl Alcohol, Cetyl Palmitate, Dimethicone, Ethylhexylglycerin, Glycerine, Glyceryl Stearate, Glycine Soja (Soybean) Oil, Melaleuca Alternifolia Leaf, Phenoxyethanol, Polysorbate 60, Purified Water (Aqua), Simmondsia Chinensis (Jojoba) Seed Oil, Stearic Acid.

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  • QUESTIONS

    Questions? Comments? www.naturasil.com 1-866-371-2499 Mfd. by: Nature's Innovation, Inc., 2723 Brickton North Dr., Buford, GA 30518.

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  • PRINCIPAL DISPLAY PANEL

    NDC # 10893-083-12

    100% Natural
    Plant Extracts

    Naturasil

    120 ml (4.06 fl. oz.)     Homeopathic Medicine

    Scabies Topical Cream

    Image Scabies Topical Cream 120 ml

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  • INGREDIENTS AND APPEARANCE
    NATURASIL  SCABIES
    sulfur cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:10893-083
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 1 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    SHEA BUTTER (UNII: K49155WL9Y)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    WATER (UNII: 059QF0KO0R)  
    JOJOBA OIL (UNII: 724GKU717M)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10893-083-12 1 in 1 CARTON
    1 1 in 1 BOTTLE, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 10/01/2011
    Labeler - Nature's Innovation, Inc. (602969854)
    Establishment
    Name Address ID/FEI Business Operations
    Nature's Innovation, Inc. 602969854 manufacture
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