Leg Cramps Ointment
FDA Label NDC 54973-3202

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hyland's Inc. for the product Leg Cramps (NDC 54973-3202). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - keep out of reach of children, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active ingredientsPurpose
"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Aconitum Napellus 3X HPUSpains in joints, legs
Arnica Montana 3X HPUSstiffness, muscle soreness and pain
Ledum Palustre 3X HPUSpain and cramps in legs
Magnesium Phosphorica 10X HPUScramps in calves
Rhus Toxicodendron 6X HPUSpains and stiffness
Viscum Album 3X HPUSpains in joints

Uses

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

Warnings

For external use only.

Otc - Do Not Use

Do not use if tube seal is broken or missing.

Otc - Ask Doctor

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

Otc - Keep Out Of Reach Of Children

Keep this and all medications out of the reach of children.

Otc - Pregnancy Or Breast Feeding

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.

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