Muscle Therapy With Arnica
FDA Label NDC 54973-3085

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 Muscle Therapy With Arnica (NDC 54973-3085). 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 otc - purpose, other, otc - active ingredient, uses, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Purpose

→ Other

→ Otc - Active Ingredient

→ Uses

→ Warnings

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Inactive Ingredients

→ Principal Display Panel - 85g Tube Carton

Otc - Purpose

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

Other

Drug Facts

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.

Otc - Active Ingredient

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.

Otc - Pregnancy Or Breast Feeding

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.

Otc - Keep Out Of Reach Of Children

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.

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.