PAIN (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]

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  • PAIN (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]

PAIN (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]
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NDC 43846-0053-1
Set ID 63e73e6d-46ca-42eb-8111-28395e21d5b8
Category HUMAN OTC DRUG LABEL
Packager Peaceful Mountain, Inc.
Generic Name
Product Class
Product Number
Application Number
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  • ACTIVE INGREDIENTS:

    Calendula Officinalis 12X, Croton Tiglium 30X, Natrum Muriaticum 30X, Plantago Major 30X, Rhus Tox 30X, Sarsaparilla (Smilax Regelii) 30X.

  • INDICATIONS:

    May temporarily relieve minor aches and pains.**

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

  • 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.

    If symptoms persist, consult a doctor.

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

  • 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 spray liberally on affected area as needed. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    May temporarily relieve minor aches and pains.**

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

  • INACTIVE INGREDIENTS:

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

  • QUESTIONS:

    Dist. by Peaceful Mountain, Inc.

    Woodbine, IA 51579   888-303-3388

  • PACKAGE LABEL DISPLAY:

    PEACEFUL MOUNTAIN

    Pain Spray

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Pain Spray

  • INGREDIENTS AND APPEARANCE
    PAIN 
    calendula officinalis, croton tiglium, natrum muriaticum, plantago major, rhus tox, sarsaparilla (smilax regelii) spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43846-0053
    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 REGELII ROOT (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG) SMILAX REGELII ROOT30 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    LARREA TRIDENTATA LEAF (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 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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43846-0053-130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/25/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/25/2017
    Labeler - Peaceful Mountain, Inc. (078430707)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43846-0053) , api manufacture(43846-0053) , label(43846-0053) , pack(43846-0053)
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