Label: SHINGLES PAIN RELIEF (calendula officinalis, croton tiglium, natrum muriaticum, plantago major, rhus tox, sarsaparilla- smilax regelii liquid

  • NDC Code(s): 43846-0059-1
  • Packager: Peaceful Mountain, Inc.
  • 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 December 16, 2021

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  • 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:  itching and sensitivity, eruptions, blisters.**

    **These statements are based upon traditional homeopathic principles. 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:

    Spray liberally on affected area as needed. Children under 12 years of age: consult a doctor.

  • INDICATIONS:

    May temporarily relieve pain due to inflammation caused by but not limited to the following: itching and sensitivity, eruptions, blisters.**

    **These statements are based upon traditional homeopathic principles. 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
    www.peacefulmountain.com

  • PACKAGE LABEL DISPLAY:

    peaceful mountain

    THE HEIGHT OF HEALTH

    shingles pain

    relief

    homeopathic spray

    1 fl. oz. (30 mL)

    Shingles Pain Relief

  • INGREDIENTS AND APPEARANCE
    SHINGLES PAIN RELIEF 
    calendula officinalis, croton tiglium, natrum muriaticum, plantago major, rhus tox, sarsaparilla (smilax regelii) liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43846-0059
    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 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:43846-0059-130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/24/201609/04/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/24/201609/04/2024
    Labeler - Peaceful Mountain, Inc. (078430707)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43846-0059) , api manufacture(43846-0059) , label(43846-0059) , pack(43846-0059)
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