MUSCLE THERAPY WITH ARNICA- arnica montana, bellis perennis, hypericum perforatum, ledum palustre twig, and ruta graveolens flowering top gel

MUSCLE THERAPY WITH ARNICA by

Drug Labeling and Warnings

MUSCLE THERAPY WITH ARNICA by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Temporarily relieves the symptoms of muscle pain, soreness, bruising and swelling due to overexertion or injury.

SPL UNCLASSIFIED SECTION

Drug Facts

• Active Ingredients: Purpose
• Arnica Montana 2X HPUS: bruising; stiffness; pain; trauma
• Bellis Perennis 3X HPUS: muscular soreness; fatigue; sprains
• Hypericum Perforatum 3X HPUS: weakness in limbs; joint pain
• Ledum Palustre 3X HPUS: swelling; aches & pains; inflammation
• Ruta Graveolens 3X HPUS: pain in limbs, joints & bones

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

Uses

• Temporarily relieves the symptoms of muscle pain, soreness, bruising and swelling due to overexertion or injury.

Warnings

For External Use Only. DO NOT USE ON OPEN WOUNDS.

As with any drug, ask a doctor before use if pregnant or nursing a baby. Consult a physician if symptoms persist for more than 7 days or worsen.

Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or a poison control center immediately. Do not use if tube seal is broken or missing.

In case of emergency, 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 1-800-624-9659.

Directions

Adults and children 6 years and over: Apply as needed to affected area 3 times daily until relieved. May be applied directly before strenuos activity or injury.

Inactive Ingredients

Chondrus Crispus (Carrageenan), Hydroxyethylcellulose,Potassium Sorbate,Purified Water USP,SD Alcohol,Sodium Benzoate.

PRINCIPAL DISPLAY PANEL - 85g Tube Carton

SPEEDS RECOVERY

NDC: 54973-3085-1

Hyland's ®

HOMEOPATHIC

SINCE 1903

Natural

Pain Relief

Muscle

Therapy™

gel

with ARNICA

Bruising

Stiffness Swelling

Joint and

Muscle Soreness

ADVANCE DEFENSE

PAIN RELIEF FORMULA

3oz 85g

MADE IN USA

INGREDIENTS AND APPEARANCE

MUSCLE THERAPY WITH ARNICA 
arnica montana, bellis perennis, hypericum perforatum, ledum palustre twig, and ruta graveolens flowering top gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3085
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	2 [hp_X]  in 1 g
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY)	BELLIS PERENNIS	3 [hp_X]  in 1 g
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	3 [hp_X]  in 1 g
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P)	LEDUM PALUSTRE TWIG	3 [hp_X]  in 1 g
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S)	RUTA GRAVEOLENS FLOWERING TOP	3 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%) (UNII: X70SE62ZAR)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Product Characteristics
Color	brown (light brown)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3085-1	1 in 1 CARTON	01/15/2009
1		85 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 54973-3085-2	5 g in 1 PACKET; Type 0: Not a Combination Product	01/15/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/15/2009

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-3085)

Establishment
Name	Address	ID/FEI	Business Operations
Diamond Wipe International, Inc.		161104729	manufacture(54973-3085) , pack(54973-3085)

Establishment
Name	Address	ID/FEI	Business Operations
Lifetech Resources		622559110	manufacture(54973-3085) , pack(54973-3085)