MUSCLE THERAPY WITH ARNICA PAIN RELIEF GEL- arnica montana,bellis perennis,hypericum perforatum,ruta graveolensflowering top and rhododendron tomentosum leafy twig gel

Muscle Therapy with Arnica Pain Relief Gel by

Drug Labeling and Warnings

Muscle Therapy with Arnica Pain Relief Gel by is a Homeopathic medication manufactured, distributed, or labeled by Hyland’s Inc., Hyland's Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Arnica Montana 1X HPUS

Bellis Perennis 2X HPUS

Hypericum Perforatum 2X HPUS

Ledum Palustre 2X HPUS

Ruta Graveolens 2X HPUS

“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Purpose

Arnica Montana 1X HPUS......................bruising, swelling,stiffness, muscle soreness and pain

Bellis Perennis 2X HPUS.................sprains, swelling and sore muscles

Hypericum Perforatum 2X HPUS.................shooting and radiating pains

Ledum Palustre 2X HPUS.......................................pain

Ruta Graveolens 2X HPUS..................sprains and twists

Uses

Temporarily relieves the symptoms of pain,

bruising, muscle soreness and swelling due to

overexertion or injury.

Warnings

For External Use Only. Keep away from eyes.

Do not use on open wounds.

Stop use and ask a doctor

If symptoms persist for more

than 7 days or worsen.

If pregnant or breast-feeding, ask a health professional

before use.

Do not use if tamper-evident tube mouth foil seal is

broken or missing.

Keep out of reach of children. If swallowed, contact a

medical professional or Poison Control Center

immediately. Hyland’s may also be contacted for

emergency information about our products 24 hours a

day, 7 days per week at (800) 624-9659.

Directions

• Adults and children 6 years and older:

  Apply liberally to affected area.

Inactive ingredients

Carbopol ® Ultrez 21

Polymer, Ethyl Alcohol, Purified Water, Sodium Hydroxide

Questions or comments?

(800) 624-9659

SPL UNCLASSIFIED SECTION

Homeopathic active ingredients 20%

*Claims based on traditional

homeopathic practice, not accepted

medical evidence. Not FDA evaluated.

Principal Display Panel - 70.9 Grams Gel Tube Carton

NDC: 54973-3203-1

HOMEOPATHIC

NATURAL

RELIEF

SINCE 1903

Hyland's

Muscle

Therapy

WITH ARNICA

TRAIN HARDER.

RECOVER FASTER.

Pain Relief Gel

Targeted Relief of:

Soreness

Stiffness

Swelling

Bruising

2.5 OZ. (70.9 GRAMS)

INGREDIENTS AND APPEARANCE

MUSCLE THERAPY WITH ARNICA PAIN RELIEF GEL 
arnica montana,bellis perennis,hypericum perforatum,ruta graveolensflowering top and rhododendron tomentosum leafy twig gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3203
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	1 [hp_X]  in 1 g
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY)	BELLIS PERENNIS	2 [hp_X]  in 1 g
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	2 [hp_X]  in 1 g
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S)	RUTA GRAVEOLENS FLOWERING TOP	2 [hp_X]  in 1 g
RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (RHODODENDRON TOMENTOSUM LEAFY TWIG - UNII:877L01IZ0P)	RHODODENDRON TOMENTOSUM LEAFY TWIG	2 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
Color	yellow (Light Yellow to Light Tan)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3203-1	1 in 1 CARTON	08/27/2018
1		70.9 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 54973-3203-2	10 g in 1 PACKET; Type 0: Not a Combination Product	08/27/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/27/2018

Labeler - Hyland’s (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Lifetech Resources, LLC		081239587	manufacture(54973-3203) , pack(54973-3203) , label(54973-3203)