Label: SHAH PAIN RELIEF- atropa belladonna, caulophyllum thalictroides root, cimicifuga, hypericum perforatum, rhododendron tomentosum leafy twig, arnica montana, calendula officinalis flowering top, ruta graveolens flowering top gel

  • 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 November 11, 2021

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  • Active Ingredients

    Active Ingredients Purpose

    All acitve ingredients are HPUS* & 3X potency.

    Belladonna, Caulophyluum, Cimicifuga, Hypericum,

    Ledum, Ruta Grav. ...................................................................Topical Analgesics

    Arnica, Calendula Off................................................................Relief of bruising and soreness

    *HPUS indicates the active ingredients are in the official Homeopathic Pharmacopeia of the United States.

  • Purpose

    Active Ingredients Purpose

    All acitve ingredients are HPUS* & 3X potency.

    Belladonna, Caulophyluum, Cimicifuga, Hypericum,

    Ledum, Ruta Grav. ...................................................................Topical Analgesics

    Arnica, Calendula Off................................................................Relief of bruising and soreness

    *HPUS indicates the active ingredients are in the official Homeopathic Pharmacopeia of the United States.

  • Uses

    Uses for temporary relief of occasional:

    • Minor aches and pains.
    • Stiffness of muscles, joints and tissues.

    Indications are based on homeopathic materia medica, not clinical tests.

  • Warnings

    Warnings

    For external use only

    Do not use

    • on damaged or broken skin
  • Do not use

    Do not use on damaged or broken skin.

    Keep ouf of

    • eyes
    • open wounds
    • mucous membranes
  • Stop use and ask doctor if

    Stop use and ask doctor if

    • condition worsens or persists
    • rash develops
  • Ask a doctor

    Stop use and ask doctor if

    • condition worsens or persists
    • rash develops

    Ask a doctor before use if you are

    • taking a prescription drug or have a serious medical condition.
  • If pregnant or breastfeeding

    If pregnant or breastfeeding

    • consult your doctor before use.
  • 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

    Directions

    • Adults and children 2 years of age and older, apply a thin layer of cream on clean skin to cover the affected area.
    • For best results, allow cream to be absorbed into the skin; do not rub in.
    • Apply at the onset of symptoms, not more than 6 times daily or every 15 minutes for the first hour.
    • Do not use with other topical remedies or lotions.
  • Other information

    Other Information

    • Store in a cool, dry place.
    • Avoid direct sunlight.
    • Tamper-evident for your protection. Use only if safety seal in intact.
    • Report serious side effects to 616-805-9642
  • Inactive Ingredients

    Inactive Ingredients

    Purified Water, Lauryl Glucoside & Myristyl Glucoside & Polyglyceryl-6-Laurate, Caprylyl Glycol, CBD Isolate, Carbopol, Sodium Hydroxide, Potassium Sorbate, Citric Acid, Saffron

  • Questions or comments?

    Questions or comments? 616-805-9642

    Monday through Friday, 8 a.m. - 5 p.m. EST or visit us at shahcbd.com

    Product efficacy and claims are based on theories of homeopathy that are not supported by scientific evidence and most modern allopathic medical professionals.

  • Package Label Display Panel 1

    Shah Pain Relief Cream Panel 1

    Package Label Display Panel 2

    Shah Pain Relief Cream Panel 2

    Package Label Display Panel 3

    Shah Pain Relief Cream Panel 3

  • INGREDIENTS AND APPEARANCE
    SHAH PAIN RELIEF 
    atropa belladonna, caulophyllum thalictroides root, cimicifuga, hypericum perforatum, rhododendron tomentosum leafy twig, arnica montana, calendula officinalis flowering top, ruta graveolens flowering top gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58368-017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH) (CAULOPHYLLUM THALICTROIDES ROOT - UNII:JTJ6HH6YEH) CAULOPHYLLUM THALICTROIDES ROOT3 [hp_X]  in 1 g
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH3 [hp_X]  in 1 g
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA3 [hp_X]  in 1 g
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM3 [hp_X]  in 1 g
    RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP3 [hp_X]  in 1 g
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA3 [hp_X]  in 1 g
    RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (RHODODENDRON TOMENTOSUM LEAFY TWIG - UNII:877L01IZ0P) RHODODENDRON TOMENTOSUM LEAFY TWIG3 [hp_X]  in 1 g
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP3 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYGLYCERIN-6 (UNII: M51422LRAM)  
    WATER (UNII: 059QF0KO0R)  
    LAURIC ACID (UNII: 1160N9NU9U)  
    MYRISTYL GLUCOSIDE (UNII: 6AK28695LF)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SAFFRON (UNII: E849G4X5YJ)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58368-017-0128.3 g in 1 JAR; Type 0: Not a Combination Product10/27/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/27/2019
    Labeler - BioLyte Laboratories, LLC (015560564)
    Establishment
    NameAddressID/FEIBusiness Operations
    BioLyte Laboratories, LLC015560564manufacture(58368-017)
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