Label: VIOLA COMP. SPECIAL ORDER gel

  • 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 November 4, 2014

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  • INDICATIONS & USAGE

    Directions: FOR TOPICAL USE ONLY.

  • DOSAGE & ADMINISTRATION

    Apply to skin as needed. Under age 2: Consult a doctor.

  • ACTIVE INGREDIENT

    Active Ingredients: 100 gm contains: 5 gm Viola odor. ex herba 1X, Urtica dioica e pl. tota 1X; Sambucus e flor. 2X, Stibium metallicum 5X

  • INACTIVE INGREDIENT

    Inactive Ingredients: Distilled water, Glycerin, Sodium alginate, Lavender oil, Potassium sorbate, Grapefruit seed extract

  • PURPOSE

    Use: Temporary relief of skin rash.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • WARNINGS

    Warnings: FOR EXTERNAL USE ONLY. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions, if conditions worsen or persist, or accidental ingestion occurs. If pregnant or nursing, consult a doctor before use. Avoid contact with eyes. Do not use if safety seal is broken or missing.

  • QUESTIONS

    Questions? Call 866.642.2858 Made with care by Uriel, East Troy, WI 53120 www.urielpharmacy.com

  • PRINCIPAL DISPLAY PANEL

    PRODUCT LABEL

  • INGREDIENTS AND APPEARANCE
    VIOLA COMP. SPECIAL ORDER 
    viola comp. special order gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48951-9047
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VIOLA ODORATA FLOWERING TOP (UNII: 04BPC87I4H) (VIOLA ODORATA FLOWERING TOP - UNII:04BPC87I4H) VIOLA ODORATA FLOWERING TOP1 [hp_X]  in 1 g
    URTICA DIOICA (UNII: 710FLW4U46) (URTICA DIOICA - UNII:710FLW4U46) URTICA DIOICA1 [hp_X]  in 1 g
    SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP2 [hp_X]  in 1 g
    ANTIMONY (UNII: 9IT35J3UV3) (ANTIMONY - UNII:9IT35J3UV3) ANTIMONY5 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48951-9047-560 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/01/2009
    Labeler - Uriel Pharmacy Inc. (043471163)
    Establishment
    NameAddressID/FEIBusiness Operations
    Uriel Pharmacy Inc.043471163manufacture(48951-9047)
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