LEG CRAMPS- aconitum napellus, arnica montana, ledum palustre twig, magnesium phosphate, dibasic trihydrate, toxicodendron pubescens leaf, and viscum album fruiting top ointment

Leg Cramps by

Drug Labeling and Warnings

Leg Cramps by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's, Standard Homeopathic Company, Diamond Wipes. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Aconitum Nap. 3X HPUS	shooting pains in legs
Arnica Mont. 3X HPUS	leg pain that starts low and moves up leg
Ledum Pal. 3X HPUS	cramp-like tension in knees, calves, heels
Magnesia Phos. 10X HPUS	cramps in calves
Rhus Tox. 6X HPUS	leg pain relieved by warmth
Viscum Alb. 3X HPUS	shooting pains in legs

Uses

Temporarily relieves the symptoms of cramps and pains in legs and calves.

Warnings

For external use only.

Do not use if tube seal is broken or missing.

If symptoms persist for more than 7 days or worsen, contact a licensed health care provider.

Keep this and all medications out of the reach of children. 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 (800) 624-9659.

Directions

Apply liberally to affected area. Hyland's Leg Cramps Ointment will warm the area while easing the symptoms.

Inactive Ingredients

Butylparaben N.F., Glyceryl Monostearate N.F., Kokam Butter, Methylparaben N.F., Olive Oil N.F., Propylparaben N.F., Purified Water, Soy Lecithin N.F., Stearyl Alcohol N.F., Wintergreen Oil Natural.

PRINCIPAL DISPLAY PANEL - 70.9 g Tube Carton

Natural
Pain
Relief

NDC: 54973-7514-33
HOMEOPATHIC
SINCE 1903

Stop the Pain!

Hyland's®
Leg
Cramps

OINTMENT

Relax Calf and
Foot Cramps

Fast-Acting Warming
Non-Greasy Wintergreen Scent

2.5 OZ/70.9 GRAMS

INGREDIENTS AND APPEARANCE

LEG CRAMPS 
aconitum napellus, arnica montana, ledum palustre twig, magnesium phosphate, dibasic trihydrate, toxicodendron pubescens leaf, and viscum album fruiting top ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-7514
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	3 [hp_X]  in 1 g
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	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
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	10 [hp_X]  in 1 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	6 [hp_X]  in 1 g
VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP) (VISCUM ALBUM FRUITING TOP - UNII:BK9092J5MP)	VISCUM ALBUM FRUITING TOP	3 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
OLIVE OIL (UNII: 6UYK2W1W1E)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
METHYL SALICYLATE (UNII: LAV5U5022Y)
GARCINIA INDICA FRUIT (UNII: 0Q3R71D98M)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-7514-3	1 in 1 CARTON	09/18/2003
1		70.9 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 54973-7514-2	4.8 g in 1 TUBE; Type 0: Not a Combination Product	09/18/2003
3	NDC: 54973-7514-4	10 g in 1 PACKET; Type 0: Not a Combination Product	09/18/2003

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/18/2003

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-7514)

Establishment
Name	Address	ID/FEI	Business Operations
Diamond Wipes		161104729	pack(54973-7514)