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

  • 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 July 26, 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.**

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

  • WARNINGS:

    For exteranl use only. If pregnant or breastfeeding, 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: itching and sensitivity, eruptions, blisters.**

    **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

    SHINGLES PAIN

    RELIEF

    Topical 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) spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44911-0334
    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 a  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 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:44911-0334-130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/23/201604/27/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/23/201604/27/2025
    Labeler - Energique, Inc. (789886132)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(44911-0334) , api manufacture(44911-0334) , label(44911-0334) , pack(44911-0334)
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