Label: RHUS TOX 4X, 8X, 12X- rhus toxicodendron. liquid

  • 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 8, 2017

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS (HPUS*):

    Rhus Toxicodendron 4X, 8X, 12X

    * The letters "HPUS" indicate the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.

  • INDICATIONS & USAGE

    USES: Temporarily relieves blistering rash.**

    ** These statements have not been reviewed by the FDA. They are based on traditional homeopathic practice.

    Temporarily relieves blistering rash.**

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Adults & children above 12 years: 3 dropperfulls in mouth and hold for 1 minute before swallowing. Repeat once a week for 3 weeks, or as directed by a health care professional.

  • WARNINGS

    WARNINGS:

    • Consult a physician for use in children under 12 years of age.
    • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
    • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
    • Do not use if TAMPER EVIDENT seal is broken or missing.

    Keep out of reach of children.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: Purified Water, Ethyl Alcohol USP.

  • QUESTIONS

    QUESTIONS & COMMENTS?:

    Little Drug / Sweetwater, TN 37874 / 423-337-7933

  • PRINCIPAL DISPLAY PANEL

    LITTLE DRUG

    FAMILY WELLNESS CENTER

    NDC: 66096-715-02

    RHUS TOX

    4X, 8X, 12X

    HOMEOPATHIC

    1 fl oz (30 mL) / 20% Alcohol

    1oz bottle label

  • INGREDIENTS AND APPEARANCE
    RHUS TOX 4X, 8X, 12X 
    rhus toxicodendron. liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66096-715
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF4 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66096-715-0230 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product03/06/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/06/2017
    Labeler - OHM PHARMA INC. (030572478)
    Registrant - OHM PHARMA INC. (030572478)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHM PHARMA INC.030572478manufacture(66096-715)
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