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 Inc., Lifetech Resources. 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 Napellus 3X HPUS	pains in joints, legs
Arnica Montana 3X HPUS	stiffness, muscle soreness and pain
Ledum Palustre 3X HPUS	pain and cramps in legs
Magnesium Phosphorica 10X HPUS	cramps in calves
Rhus Toxicodendron 6X HPUS	pains and stiffness
Viscum Album 3X HPUS	pains in joints

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.

If pregnant or breast-feeding, ask a health professional before use. 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

Beeswax, Cetearyl Alcohol, Citric Acid, Potassium Sorbate, Purified Water, Sodium Benzoate, Sodium Stearoyl Glutamate, Vegetable Glycerine, Vegetable Oil, Wintergreen Extract, Xanthan Gum.

PRINCIPAL DISPLAY PANEL - 70.9 g Tube Carton

NDC: 54973-3202-1

HOMEOPATHIC

Natural

Relief

SINCE 1903

Hyland's®

Leg Cramps

OINTMENT

Relax Calf and Foot Cramps*

2.5 OZ/

70.9 GRAMS

Fast-Acting Deep-Penetrating Warming

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: 54973-3202
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
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
GLYCERIN (UNII: PDC6A3C0OX)
CORN OIL (UNII: 8470G57WFM)
GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3202-1	1 in 1 CARTON	05/12/2015
1		70.9 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 54973-3202-2	10 g in 1 TUBE; Type 0: Not a Combination Product	05/12/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/12/2015

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-3202) , pack(54973-3202)

Establishment
Name	Address	ID/FEI	Business Operations
Lifetech Resources		622559110	manufacture(54973-3202) , pack(54973-3202)