Label: NATURASIL SCABIES- sulfur cream

  • NDC Code(s): 10893-420-02, 10893-420-04
  • 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 January 14, 2021

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  • 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.

  • PURPOSE

    Purpose: Scabies Symptom Relief

  • INDICATIONS & USAGE

    Uses:  Symptomatic treatment of scabies

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions:  Cleanse skin thoroughly before applying. Cover the affected area 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 to use Naturasil Sulfur Lavender Soap. Some individuals may be senstive to sulfur or essential oils. Skin test for tolerability. If irritation or reaction occurs, discontinue use.

  • 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, Polysorbate 60, Phenoxyethanol, Purified Water (Aqua), Simmondsia Chinensis (Jojoba) Seed Oil, Stearic Acid. 

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    NDC# 10893-420-_

    100% Natural

    Plant Extracts

    Naturasil

    __ml

    (__ fl. oz.)  Homeopathic Medicine

    Scabies Topical Cream

    60 mL

    120 mL

  • INGREDIENTS AND APPEARANCE
    NATURASIL  SCABIES
    sulfur cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10893-420
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR1 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    JOJOBA OIL (UNII: 724GKU717M)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10893-420-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product01/11/2012
    2NDC:10893-420-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product01/11/201201/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/11/2012
    Labeler - Nature's Innovation, Inc. (602969854)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nature's Innovation, Inc.602969854manufacture(10893-420)
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