Plant 2 Product Allevatio by BioLyte Laboratories, LLC

Plant 2 Product Allevatio by

Drug Labeling and Warnings

Plant 2 Product Allevatio by is a Homeopathic medication manufactured, distributed, or labeled by BioLyte Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PLANT 2 PRODUCT ALLEVATIO- homeopathic pain relief 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 Ingredient

Active Ingredients Purpose

All active ingredients are HPUS* & 3X potency.

Aesculus Hipp., Caulophyllum, Cimicifuga

Racemosa, Hypericum, Ledum, Rhamnus Calif,

Ruta Grav...............................................................Topical Analygesics

Arnica Montana......................................................Anti-inflammatory

Calendula...............................................................Relief for bruising and soreness

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

Purpose

Active Ingredients Purpose

All active ingredients are HPUS* & 3X potency.

Aesculus Hipp., Caulophyllum, Cimicifuga

Racemosa, Hypericum, Ledum, Rhamnus Calif,

Ruta Grav...............................................................Topical Analygesics

Arnica Montana......................................................Anti-inflammatory

Calendula...............................................................Relief for 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 of muscles and joints associated with
  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Indications are based on homeopathic materia medica not clinical tests.

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

Warnings

Warnings

For external use only.

Ask a doctor before use if

As a doctor before use if: taking a prescription drug or have a serious medical condition.

When using this product

When using this product: Avoid contact with eyes or mucous membranes

  • Do not use with other ointments, creams or sprays.
  • Do not apply over large areas of the body or bandage
  • Do not use with heating pad or device

Stop use and ask a doctor if

Stop use and ask a doctor if: condition worsens, or if symptoms persist for more than seven (7) days, or clear up and reoccur.

Stop use and ask a doctor if

Stop use and ask a doctor if: condition worsens, or if symptoms persist for more than seven (7) days, or clear up and reoccur.

If pregnant or breast-feeding

If pregnant or breast-feeding: Ask a healthcare professional before use.

Keep out of reach of children:

Keep out of reach of children: If accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Directions:

  • Adults and children 2 years age and older, apply a thin layer of gel on clean skin to cover the affected area.
  • For best results, allow gel to be absorbed into the skin; do not rub in.
  • Apply at the onset of symptoms, or every 15 minutes for the first hour, but not more than 6 times daily.
  • Children under 2 years of age: Consult a doctor.

Other Information

Other Information

  • Store in a cool, dry place.
  • Avoid direct sunlight.
  • Tamper-evident for your protection. Use only if safety seal is intact.

Inactive Ingredients

Inactive Ingredients

Cannabidiol (CBD), *Caprylyl Glycol, Carbomer, Citric Acid, *Ethylhexylglycerin, *Lauryl Glucoside, *Myristyl, Glucoside, *Polyglyceryl-6-Laurate, Potassium Sorbate, Purified Water, Sodium Hydroxide

*Plant Based Ingredients

Questions or Comments?

Questions or Comments?

1-833-4-USA-CBD or visit us at LumenCBD.com

Hours of Operations: M-F 8:00a -6:00p (EST)

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PLANT 2 PRODUCT ALLEVATIO 
homeopathic pain relief gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58368-019
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FRANGULA CALIFORNICA BARK (UNII: 1LZ13MQR0S) (FRANGULA CALIFORNICA BARK - UNII:1LZ13MQR0S) FRANGULA CALIFORNICA BARK3 [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
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP3 [hp_X]  in 1 g
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM3 [hp_X]  in 1 g
HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT3 [hp_X]  in 1 g
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA3 [hp_X]  in 1 g
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
RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (RHODODENDRON TOMENTOSUM LEAFY TWIG - UNII:877L01IZ0P) RHODODENDRON TOMENTOSUM LEAFY TWIG3 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLYGLYCERIN-6 (UNII: M51422LRAM)  
LAURIC ACID (UNII: 1160N9NU9U)  
WATER (UNII: 059QF0KO0R)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CANNABIDIOL (UNII: 19GBJ60SN5)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
MYRISTYL GLUCOSIDE (UNII: 6AK28695LF)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58368-019-0156.7 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/19/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/19/202010/14/2021
Labeler - BioLyte Laboratories, LLC (015560564)
Establishment
NameAddressID/FEIBusiness Operations
BioLyte Laboratories, LLC015560564manufacture(58368-019)

Revised: 1/2023