Label: PAIN AWAY SOLUTION- aconitum nepellus hypericum peforatum lycopodium clavatum phosphorus rhus toxicodendron secale cornutum spray

  • NDC Code(s): 65121-887-01, 65121-887-02, 65121-887-03
  • Packager: Pure Source, LLC
  • 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 August 25, 2017

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Aconitum Napellus, 24X HPUS

    Hypericum Peforatum, 24X HPUS

    Lycopodium Clavatum, 24X HPUS

    Phosphorus, 24X HPUS

    Rhus Toxicodendron, 24X HPUS

    Secale Cornuum, 24X HPUS

  • PURPOSE

    Nerve Pain Relief

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away - (800-222-1222)

  • INDICATIONS & USAGE

    Use

    For the temporary relief of nerve pain

  • WARNINGS

    Warnings

    For external use only.

    Do not use on wounds or damaged skin.

    Stop use and ask doctor if

    • Symptoms persist for more than seven days.
    • If irritation occurs, discontinue use.

    When using this product

    • Avoid contact with eyes.
    • Do not wrap treated area with bandage.

    If pregnant or breast feeding, ask a health professional before use.

  • DOSAGE & ADMINISTRATION

    Directions

    • Spray small amount to cover the affected area.
    • Do not apply more than 4 times daily.
    • Avoid contact with eyes and mucus membranes.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Bergamot Oil, Cassia Leaf Oil, Eucalyptus Oil, Geranium Oil, Histamine Dihydrochloride, Lavender Oil, Safflower Oil, SD-Alcohol 38B, Tea Tree Oil

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    PAIN AWAY SOLUTION 
    aconitum nepellus hypericum peforatum lycopodium clavatum phosphorus rhus toxicodendron secale cornutum spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65121-887
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM24 [hp_X]  in 100 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE24 [hp_X]  in 100 mL
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS24 [hp_X]  in 100 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS24 [hp_X]  in 100 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF24 [hp_X]  in 100 mL
    CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N) CLAVICEPS PURPUREA SCLEROTIUM24 [hp_X]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
    CHINESE CINNAMON LEAF OIL (UNII: 4U4V2F2E4Y)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    HISTIDINE MONOHYDROCHLORIDE (UNII: 1D5Q932XM6)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65121-887-0110 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/25/2017
    2NDC:65121-887-0215 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/25/2017
    3NDC:65121-887-0315 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/25/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/25/2017
    Labeler - Pure Source, LLC (080354456)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source, LLC080354456manufacture(65121-887)