JOINT PAIN AND STIFFNESS RELIEF (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [ENERGIQUE, INC.]

JOINT PAIN AND STIFFNESS RELIEF (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [ENERGIQUE, INC.]
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NDC 44911-0304-1
Set ID 3aac6679-211f-44fd-92f6-02309df2051e
Category HUMAN OTC DRUG LABEL
Packager Energique, Inc.
Generic Name
Product Class
Product Number
Application Number
  • ACTIVE INGREDIENTS:

    (in each spray): 0.21% of Calendula Officinalis 12X, Croton Tiglium 30X, Natrum Muriaticum 30X, Plantago Major 30X, Rhus Tox 30X, Sarsaparilla (Smilax Regelii) 30X.

  • INDICATIONS:

    May temporarily relieve pain due to inflammation caused by but not limited to the following: sprains, minor joint inflammation, trauma.**

    **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • WARNINGS:

    For external use only.

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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    Do not get into eyes.

    Do not use if tamper evident seal is broken or missing.

    SHAKE WELL

  • 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.

  • DIRECTIONS:

    Adults and children shake well and spray liberally on affected area as needed. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    May temporarily relieve pain due to inflammation caused by but not limited to the following: sprains, minor joint inflammation, trauma.**

    **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • INACTIVE INGREDIENTS:

    Aloe Vera Leaf Juice, Arnica Flower*, Caprylyl Glycol, Chaparral Leaf*, Citric Acid, Comfrey Leaf*, Dragon's Blood Croton Sap, English Lavender Buds*, Ethanol, Ionic Colloidal Silver, Lemon Balm Leaf*, PEG-8 Dimethicone, PEG-14, PEG-33, Phenoxyethanol, Poke Berries*, Poke Root*, Potassium Sorbate, Purified Water, Sodium Benzoate, Sodium Bicarbonate, Sorbic Acid, St. John's Wort Aerial Parts*, Tocopherols (soy), Vitamin C, Whey Protein Concentrate (Milk), White Willow Bark* and Yarrow Flower*.

  • QUESTIONS:


    Dist. by Energique, Inc., 201 Apple Blvd.
    Woodbine, IA 51579   800.869.8078

  • PACKAGE LABEL DISPLAY:

    ENERGIQUE

    SINCE 1987

    HOMEOPATHIC REMEDY

    JOINT PAIN

    & STIFFNESS

    RELIEF

    Topical Spray

    1 fl. oz. (30 ml)

    Joint Pain and Stiffness Relief

    Joint Pain and Stiffness Relief

  • INGREDIENTS AND APPEARANCE
    JOINT PAIN AND STIFFNESS RELIEF 
    calendula officinalis, croton tiglium, natrum muriaticum, plantago major, rhus tox, sarsaparilla (smilax regelii) spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44911-0304
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP12 [hp_X]  in 1 mL
    CROTON TIGLIUM SEED (UNII: 0HK2GZK66E) (CROTON TIGLIUM SEED - UNII:0HK2GZK66E) CROTON TIGLIUM SEED30 [hp_X]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE30 [hp_X]  in 1 mL
    PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR30 [hp_X]  in 1 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF30 [hp_X]  in 1 mL
    SMILAX ORNATA ROOT (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG) SMILAX ORNATA ROOT30 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    LARREA TRIDENTATA TOP (UNII: PK0TXD049P)  
    COMFREY LEAF (UNII: DG4F8T839X)  
    CROTON LECHLERI RESIN (UNII: GGG6W25C63)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    SILVER (UNII: 3M4G523W1G)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SORBIC ACID (UNII: X045WJ989B)  
    PHYTOLACCA AMERICANA FRUIT (UNII: WE63661499)  
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    WHEY (UNII: 8617Z5FMF6)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA)  
    ALCOHOL (UNII: 3K9958V90M)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44911-0304-130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/18/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/18/2015
    Labeler - Energique, Inc. (789886132)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(44911-0304) , api manufacture(44911-0304) , label(44911-0304) , pack(44911-0304)

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