Label: BACK HP- aconitum napellus, horse chestnut, colchicum autumnale bulb, hypericum perforatum, magnesium phosphate dibasic trihydrate, lead, toxicodendron pubescens leaf, arnica montana liquid

  • NDC Code(s): 43406-0622-1
  • Packager: Natural Creations, 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 December 19, 2022

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Aconitum Napellus 30X, Aesculus Hippocastanum 30X, Colchicum Autumnale 30X, Hypericum Perforatum 30X, Magnesia Phosphorica 30X, Plumbum Metallicum 30X, Rhus Toxicodendron 30X, Arnica Montana 30C.

  • PURPOSE

    USES: Temporarily relieves minor back, limb, & body aches.**

  • INDICATIONS & USAGE

    USES: Temporarily relieves minor back, limb, & body aches.**

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Adults & children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

  • KEEP OUT OF REACH OF CHILDREN

    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.

  • 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.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water.

  • QUESTIONS

    QUESTIONS & COMMENTS?:

    Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

  • REFERENCES

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

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

    LOT:

  • PRINCIPAL DISPLAY PANEL

    NDC: 43406-0622-1

    BACK HP

    HOMEOPATHIC

    1 fl oz (30 mL) / 20% Alcohol

    UPC: 877730004642 NON GMO Logo

    image description

  • INGREDIENTS AND APPEARANCE
    BACK HP 
    aconitum napellus, horse chestnut, colchicum autumnale bulb, hypericum perforatum, magnesium phosphate dibasic trihydrate, lead, toxicodendron pubescens leaf, arnica montana liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43406-0622
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS30 [hp_X]  in 1 mL
    HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT30 [hp_X]  in 1 mL
    COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6) COLCHICUM AUTUMNALE BULB30 [hp_X]  in 1 mL
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM30 [hp_X]  in 1 mL
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE30 [hp_X]  in 1 mL
    LEAD (UNII: 2P299V784P) (LEAD - UNII:2P299V784P) LEAD30 [hp_X]  in 1 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF30 [hp_X]  in 1 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43406-0622-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product06/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/01/2016
    Labeler - Natural Creations, Inc. (018022074)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHM Pharma, Inc.030572478manufacture(43406-0622)
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