PAIN SUPPRESS FOR WOMEN (ARNICA MONTANA, BERBERIS VULGARIS, CHAMOMILLA, HYPERICUM PERFORATUM, NATRUM MURIATICUM, OOPHORINUM (SUIS), PLANTAGO MAJOR, RHODODENDRON CHRYSANTHUM, SARSAPARILLA (SMI

PAIN SUPPRESS FOR WOMEN (ARNICA MONTANA, BERBERIS VULGARIS, CHAMOMILLA, HYPERICUM PERFORATUM, NATRUM MURIATICUM, OOPHORINUM (SUIS), PLANTAGO MAJOR, RHODODENDRON CHRYSANTHUM, SARSAPARILLA (SMI
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NDC 71166-0002-1
Set ID 8dccec96-47fa-4380-b774-df0bbad7db4e
Category HUMAN OTC DRUG LABEL
Packager Amore Energia, LLC
Generic Name
Product Class
Product Number
Application Number
  • ACTIVE INGREDIENTS:

    Arnica Montana 30X, Berberis Vulgaris 30X, Chamomilla 30X, Hypericum Perforatum 30X, Natrum Muriaticum 30X, Oophorinum (Suis) 30X, Plantago Major 30X, Rhododendron Chrysanthemum 30X, Sarsaparilla (Smilax Regelii) 30X, Sepia 30X, Sulphur 30X, Veratrum Album 30X.

  • INDICATIONS:

    May provide temporary relief of subjective pain due to inflammation and/or injury.**

    **These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

  • WARNINGS:

    If pregnant or breastfeeding, ask a health professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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

    Store in a cool, dry place.

  • KEEP OUT OF REACH OF CHILDREN:

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS:

    Shake before use.

    Two sprays, within the mouth, three times a day.

    Repeat daily, as needed for general relief.

    Consult with your health care provider for use in children under 12 years of age.

  • INDICATIONS:

    May provide temporary relief of subjective pain due to inflammation and/or injury.**

    **These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

  • INACTIVE INGREDIENTS:

    Demineralized Water, Ethanol 20%

  • QUESTIONS:

    Dist. by Amore Energia, LLC

    8001 Chicago Street

    Omaha, NE 68114

  • PACKAGE LABEL DISPLAY:

    Amore Energia

    Pain Suppress

    for Women

    Homeopathic Spray

    2 fl. oz. (60 ml)

    Pain Suppress for Women

  • INGREDIENTS AND APPEARANCE
    PAIN SUPPRESS FOR WOMEN 
    arnica montana, berberis vulgaris, chamomilla, hypericum perforatum, natrum muriaticum, oophorinum (suis), plantago major, rhododendron chrysanthum, sarsaparilla (smilax regelii), sepia, sulphur, veratrum album liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71166-0002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [hp_X]  in 1 mL
    BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK30 [hp_X]  in 1 mL
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA30 [hp_X]  in 1 mL
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM30 [hp_X]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE30 [hp_X]  in 1 mL
    SUS SCROFA OVARY (UNII: S7YTV04R8O) (SUS SCROFA OVARY - UNII:S7YTV04R8O) SUS SCROFA OVARY30 [hp_X]  in 1 mL
    PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR30 [hp_X]  in 1 mL
    RHODODENDRON AUREUM LEAF (UNII: IV92NQJ73U) (RHODODENDRON AUREUM LEAF - UNII:IV92NQJ73U) RHODODENDRON AUREUM LEAF30 [hp_X]  in 1 mL
    SMILAX ORNATA ROOT (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG) SMILAX ORNATA ROOT30 [hp_X]  in 1 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE30 [hp_X]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR30 [hp_X]  in 1 mL
    VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z) VERATRUM ALBUM ROOT30 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71166-0002-160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/18/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/18/2018
    Labeler - Amore Energia, LLC (080487870)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(71166-0002) , api manufacture(71166-0002) , label(71166-0002) , pack(71166-0002)

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