NEORELIEF FOR PAIN- topical gel for pain gel

NEORELIEF FOR PAIN by

Drug Labeling and Warnings

NEORELIEF FOR PAIN by is a Homeopathic medication manufactured, distributed, or labeled by BioLyte Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts Active Ingredients

All active ingredients are HPUS* and 4X potency

Actaea, Aesculus Hipp., Belladonna, Bryonia., Caulophyllum, Causticum, Cimicifuga, Gauiacum, Hypericum, Kali Carb., Ledum, Lithium Carb., Rhamnus Calif., Rhododendron, Rhus. Tox., Ruta Grav., Salicylicum Ac., Setllaria Med.

Althaea

Arnica, Bellis, Calendula

Purpose

Topical Analgesics

Anti-inflammatory

Relief of bruising and soreness

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

For external use only

Do not use on damaged or broken skin.

Keep out of eyes, open wounds, mucous membranes.

Warnings

Stop use and ask doctor if condition worsens or persists, rash develeops

Warnings

Ask a doctor before use if you are taking a prescription drug or have a serious medical condition.

Warnings

If pregnant or breatfeeding consult your doctor before use.

Warnings

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, 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, 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

• Store in a cool, dry place.
• Avoid direct sunlight.
• Tamper-evident for your protection. Use only if safety seal is intact.
• Report all serious side effects to 800.538.1455

Inactive Ingredients

Citric Acid, Fulvic Acid, Glycerin, Potassium Sorbate, Purified Water, Sodium Hydroxide, Ultrez-10 Polymer

Questions or comments?

800.538.1455

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

Additional Label Content

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

Made in the USA

Listed with the FDA

(UPC code: 3 58368 00501 5)

Drug Facts continued Peel Here

Packaging Recyclable

neorelief.com

BioLyte laboratories- Grand Rapids, MI 49534

NEORELIEF for PAIN 56.7g Bottle

NDC: 58368-005-01 Patented

NeoRelief

Pain

Temporary relief of minor aches and pains, and stiffness of muscles and joints

Homeopathic

pain relief gel

Net Wt. 2.0 oz (56.7g)

INGREDIENTS AND APPEARANCE

NEORELIEF FOR PAIN 
topical gel for pain gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58368-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY)	BELLIS PERENNIS	4 [hp_X]  in 1 g
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	4 [hp_X]  in 1 g
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	4 [hp_X]  in 1 g
CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH) (CAULOPHYLLUM THALICTROIDES ROOT - UNII:JTJ6HH6YEH)	CAULOPHYLLUM THALICTROIDES ROOT	4 [hp_X]  in 1 g
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU)	CAUSTICUM	4 [hp_X]  in 1 g
GUAIACUM OFFICINALE RESIN (UNII: N0K2Z502R6) (GUAIACUM OFFICINALE RESIN - UNII:N0K2Z502R6)	GUAIACUM OFFICINALE RESIN	4 [hp_X]  in 1 g
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	4 [hp_X]  in 1 g
LITHIUM CARBONATE (UNII: 2BMD2GNA4V) (LITHIUM CATION - UNII:8H8Z5UER66)	LITHIUM CARBONATE	4 [hp_X]  in 1 g
FRANGULA CALIFORNICA BARK (UNII: 1LZ13MQR0S) (FRANGULA CALIFORNICA BARK - UNII:1LZ13MQR0S)	FRANGULA CALIFORNICA BARK	4 [hp_X]  in 1 g
RHODODENDRON AUREUM LEAF (UNII: IV92NQJ73U) (RHODODENDRON AUREUM LEAF - UNII:IV92NQJ73U)	RHODODENDRON AUREUM LEAF	4 [hp_X]  in 1 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	4 [hp_X]  in 1 g
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S)	RUTA GRAVEOLENS FLOWERING TOP	4 [hp_X]  in 1 g
HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ)	HORSE CHESTNUT	4 [hp_X]  in 1 g
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	4 [hp_X]  in 1 g
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	4 [hp_X]  in 1 g
STELLARIA MEDIA (UNII: 2H03479QVR) (STELLARIA MEDIA - UNII:2H03479QVR)	STELLARIA MEDIA	4 [hp_X]  in 1 g
ACTAEA SPICATA ROOT (UNII: 3FU86L9OS0) (ACTAEA SPICATA ROOT - UNII:3FU86L9OS0)	ACTAEA SPICATA ROOT	4 [hp_X]  in 1 g
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H) (ALTHAEA OFFICINALIS ROOT - UNII:TRW2FUF47H)	ALTHAEA OFFICINALIS ROOT	4 [hp_X]  in 1 g
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	4 [hp_X]  in 1 g
ATROPA BELLADONNA ROOT (UNII: 6MW97Q6E8M) (ATROPA BELLADONNA ROOT - UNII:6MW97Q6E8M)	ATROPA BELLADONNA ROOT	4 [hp_X]  in 1 g
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	4 [hp_X]  in 1 g
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P)	LEDUM PALUSTRE TWIG	4 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FULVIC ACID (UNII: XII14C5FXV)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58368-005-01	56.7 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/01/2017

Labeler - BioLyte Laboratories, LLC (015560564)

Establishment
Name	Address	ID/FEI	Business Operations
BioLyte Laboratories, LLC		015560564	label(58368-005) , manufacture(58368-005) , pack(58368-005)