Label: WELL-EX- arsenicum alb, graphites, hepar sulph calc, radium brom, viola tric spray

  • 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 June 13, 2016

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  • HPUS Active Ingredients

    Each does contains equal parts of: Arsenicum alb (6C), Graphites (6C), Hepar sulph calc (6C), Radium brom (30C), Viola tric (6C).

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  • Uses

    Soothes transient itching and weeping of skin during an eczema 'flare up'.

    This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

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  • Warnings

    If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a health professional before use. Keep this and all medication out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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  • Directions

    Initially, depress pump until primed. Hold close to mouth and spray directly into mouth. Use three times daily, 30 minutes before food, until symptoms subside. Adults: 3 pump sprays. Children 2-12: 2 pump sprays.

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  • Other Information

    All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness.For more information, visit us at www.nativeremedies.com. Contains no artificial flavors or colorants. No gluten added.

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  • INACTIVE INGREDIENT

    Citric acid, potassium sorbate, purified water.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medication out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

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  • PURPOSE

    Soothes symptoms of transient skin flare-ups in children with eczema or atopic dermatitis

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  • INGREDIENTS AND APPEARANCE
    WELL-EX 
    arsenicum alb, graphites, hepar sulph calc, radium brom, viola tric spray
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68703-259
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    RADIUM BROMIDE (UNII: R74O7T8569) (RADIUM CATION - UNII:05456MVL7T) RADIUM BROMIDE 30 [hp_C]  in 59 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 6 [hp_C]  in 59 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 6 [hp_C]  in 59 mL
    GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE 6 [hp_C]  in 59 mL
    VIOLA TRICOLOR (UNII: 9Q24RAI43V) (VIOLA TRICOLOR - UNII:9Q24RAI43V) VIOLA TRICOLOR 6 [hp_C]  in 59 mL
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68703-259-02 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 09/12/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 09/12/2016
    Labeler - Silver Star Brands (006070379)
    Registrant - Silver Star Brands (006070379)
    Establishment
    Name Address ID/FEI Business Operations
    King Bio 617901350 manufacture(68703-259) , api manufacture(68703-259)
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