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 
BioLyte Laboratories, LLC

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.

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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

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)

Revised: 12/2020
 
BioLyte Laboratories, LLC