Anodyne Pain Relief by BioLyte Laboratories, LLC

Anodyne Pain Relief by

Drug Labeling and Warnings

Anodyne Pain Relief by is a Homeopathic medication manufactured, distributed, or labeled by BioLyte Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANODYNE PAIN RELIEF- actaea, belladonna, bryonia, cimicifuga, ledum, rhododendron, ruga grav, arnica, salicylicum ac, bellis, hypericum cream 
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

All active ingredients are HPUS* & 3X potency.

Actaea, Belladonna, Bryonia, Cimicifuga, Ledum, Rhododendron, Ruta Grav.

Arnica, Salicylicum Ac.

Bellis, Hypercium

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

Purpose

All active ingredients are HPUS* & 3X potency.

Actaea, Belladonna, Bryonia, Cimicifuga, Ledum, Rhododendron, Ruta Grav. ............................Topical Analgesics

Arnica, Salicylicum Ac. ...........................Anti-inflammatory

Bellis, Hypercium .........................Relief of brusing and soreness

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

Uses

For temporary releif of occasional:

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

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

Warnings

For external use only.

Do not use

  • on damaged or broken skin.
  • with other topical remedies or lotions.

Keep out of

  • eyes
  • open wounds
  • mucous membranes.

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 consult your doctor before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children 2 years of age and older, liberally apply 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, not more than 6 times daily or every 15 minutes for the first hour.

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

Cannabidiol*, Caprylyl Glycol, Citric Acid, Polymer, Sodium Hydroxide, Water.

*Bio-Identical CBD not made from hemp or cannabis

Questions or comments?

  • Report serious side effects to 800.252.2056

Monday through Friday, 8 a.m. - 5 p.m. PST

or visit us at novopurecbd.com

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Anodyne Pain Relief Cream Panel 1

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ANODYNE PAIN RELIEF 
actaea, belladonna, bryonia, cimicifuga, ledum, rhododendron, ruga grav, arnica, salicylicum ac, bellis, hypericum cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58368-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA3 [hp_X]  in 1 g
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH3 [hp_X]  in 1 g
RHODODENDRON AUREUM LEAF (UNII: IV92NQJ73U) (RHODODENDRON AUREUM LEAF - UNII:IV92NQJ73U) RHODODENDRON AUREUM LEAF3 [hp_X]  in 1 g
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID3 [hp_X]  in 1 g
ATROPA BELLADONNA ROOT (UNII: 6MW97Q6E8M) (ATROPA BELLADONNA ROOT - UNII:6MW97Q6E8M) ATROPA BELLADONNA ROOT3 [hp_X]  in 1 g
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG3 [hp_X]  in 1 g
ACTAEA SPICATA ROOT (UNII: 3FU86L9OS0) (ACTAEA SPICATA ROOT - UNII:3FU86L9OS0) ACTAEA SPICATA ROOT3 [hp_X]  in 1 g
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS3 [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
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT3 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
CANNABIDIOL (UNII: 19GBJ60SN5)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58368-020-0156.7 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/16/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic11/16/202012/31/2023
Labeler - BioLyte Laboratories, LLC (015560564)
Establishment
NameAddressID/FEIBusiness Operations
BioLyte Laboratories, LLC015560564manufacture(58368-020)

Revised: 1/2024