Label: COOLING ACUTE PAIN RELIEF- aesculus hippocastanum, arnica montana, bellis perennis, bryonia, calcarea carbonica, calcarea fluorica, cimicifuga racemosa, cobaltum metallicum, gnaphalium polycephalum, hypericum perforatum, kali carbonicum, kali phosphoricum, magnesia phosphorica, oxalicum acidum, phosphorus, rhus toxicodendron, ruta graveolens, zincum metallicum cream

  • 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 February 20, 2018

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

  • ACTIVE INGREDIENT

    Drug Facts__________________________________________________________________________________________________________

    HPUS active ingredients:

    Equal volumes of each active ingredient in 10X, 30X and LM1 potencies. Active ingredients 50% of total weight.

    Aesculus hippocastanum, Arnica montana, Bellis perennis, Bryonia, Calcarea carbonica, Calcarea fluorica, Cimicifuga racemosa, Cobaltum metallicum, Gnaphalium polycephalum, Hypericum perforatum, Kali carbonicum, Kali phosphoricum, Magnesia phosphorica, Oxalicum acidum, Phosphorus, Rhus toxicodendron, Ruta graveolens, Zincum metallicum.

  • INDICATIONS & USAGE

    Uses: for temporary relief of symptoms: •back and neck pain •muscle and joint pain •muscle cramps and stiffness •inflamed muscles and joints •muscle tension and soreness •body aches •tired legs and feet •stiff and swollen joints

  • WARNINGS

    Warnings:

    • For external use only. Avoid contact with eyes and broken skin.
    • Stop use and ask a doctor if •symptoms worsen or do not improve within 7 days. •skin irritation, redness or rash occurs.
    • Nursing mothers should not apply to breast area.
    • Keep out of reach of children.
    • If swallowed, get medical help or contact a Poison Control Center immediately.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children.
  • DOSAGE & ADMINISTRATION

    Directions:

    •Shake before using. •Apply generously to affected areas 2 to 3 times daily, or more often as needed. •Massage in thoroughly until absorbed. •For best results, apply immediately after the onset of symptoms. •Reapply after bathing and before bedtime for ongoing relief. •May be used before and after exercise.

  • OTHER SAFETY INFORMATION

    Other information:

    • To open: unscrew cap, remove tube seal, replace cap.
    • Safety sealed for your protection.
    • Do not use if tube seal is missing.
    • Store at 68-77° (20-25°C).
  • INACTIVE INGREDIENT

    Inactive ingredients: Cetearyl alcohol, deionized water, glyceryl stearate, jojoba seed oil, menthol, peppermint oil, phenoxyethanol, pomegranate fruit extract, shea butter, sodium lactate, sodium stearoyl lactylate, sweet almond oil, sweet birch oil.

  • PURPOSE

     Drug Facts

    __________________________________________________________________________________________________________________

    HPUS active ingredients                                                                       Purpose

    Equal volumes of each active ingredient in 10X, 30X and LM1 potencies.

    Active ingredients 50% of total weight.

    Aesculus hippocastanum..........................................................tired legs and feet

    Arnica montana......................................................................sprains

    Bellis perennis........................................................................sore muscles

    Bryonia..................................................................................inflammation

    Calcarea carbonica..................................................................back pain

    Calcarea fluorica.....................................................................backache

    Cimicifuga racemosa...............................................................leg aches

    Cobaltum metallicum..............................................................muscle fatigue

    Gnaphalium polycephalum.......................................................leg cramps

    Hypericum perforatum............................................................cramps

    Kali carbonicum.....................................................................stiff, swollen joints

    Kali phosphoricum..................................................................backache

    Magnesia phosphorica.............................................................muscle cramps

    Oxalicum acidum....................................................................muscle aches

    Phosphorus............................................................................weak joints

    Rhus toxicodendron................................................................joint pain

    Ruta graveolens.....................................................................body aches

    Zincum metallicum.................................................................backache

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    COOLING ACUTE PAIN RELIEF 
    aesculus hippocastanum, arnica montana, bellis perennis, bryonia, calcarea carbonica, calcarea fluorica, cimicifuga racemosa, cobaltum metallicum, gnaphalium polycephalum, hypericum perforatum, kali carbonicum, kali phosphoricum, magnesia phosphorica, oxalicum acidum, phosphorus, rhus toxicodendron, ruta graveolens, zincum metallicum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-4001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT10 [hp_X]  in 85 g
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA10 [hp_X]  in 85 g
    BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS10 [hp_X]  in 85 g
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT10 [hp_X]  in 85 g
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE10 [hp_X]  in 85 g
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE10 [hp_X]  in 85 g
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH10 [hp_X]  in 85 g
    COBALT (UNII: 3G0H8C9362) (COBALT - UNII:3G0H8C9362) COBALT10 [hp_X]  in 85 g
    PSEUDOGNAPHALIUM OBTUSIFOLIUM (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM - UNII:36XQ854NWW) PSEUDOGNAPHALIUM OBTUSIFOLIUM10 [hp_X]  in 85 g
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM10 [hp_X]  in 85 g
    POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE10 [hp_X]  in 85 g
    POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC10 [hp_X]  in 85 g
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE10 [hp_X]  in 85 g
    OXALIC ACID DIHYDRATE (UNII: 0K2L2IJ59O) (OXALIC ACID - UNII:9E7R5L6H31) OXALIC ACID DIHYDRATE10 [hp_X]  in 85 g
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS10 [hp_X]  in 85 g
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF10 [hp_X]  in 85 g
    RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP10 [hp_X]  in 85 g
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC10 [hp_X]  in 85 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MENTHOL (UNII: L7T10EIP3A)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-4001-31 in 1 CARTON02/20/2018
    185 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/20/2018
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc617901350api manufacture(57955-4001)