Pain Relief
FDA Label NDC 76029-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Active Release Techniques Llc for the product Pain Relief (NDC 76029-001). 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 - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, 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

Otc - Active Ingredient

Ruta Graveolens 3X

Otc - Purpose

Topical Analgesic

Indications & Usage

for the temporary relief of minor aches, pains, soreness, and stiffness associated with simple backaches, strains, bruises, sprains, dull tearing in bones of the arm and joints of the elbow and arthritis, as per Homeopathic Materia Medica.

Warnings

for external use only

Otc - Do Not Use

Do not use

  • on wounds or damaged skin
  • in large quantities particularly over raw surfaces or blistered areas
  • with a heating pad

Otc - When Using

When using this product

  • avoid contact with eyes or mucous membranes
  • use only as directed
  • do not bandage tightly

Otc - Stop Use

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • excessive skin irritation occurs

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions

  • adults and children 2 years of age and older: apply to affected are not more than 3 to 4 times daily
  • children under 2 years of age: consult a physician


Inactive Ingredient

Inactive Ingredients

Argania Spinosa Kernel Oil, Beeswax (Cera Alba), Benzoic Acid, Calendula Officinalis Flower Extract, Cetearyl Olivate, Dehydroacetic Acid, Dromiceius, Ethoxydiglycol, Glycerin, Isopropyl Palmitate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Nymphaea Caerulea Flower Extract, Peucedanum Ostruthium Leaf Extract, Potassium Citrate, Ribes Nigrum (Black Currant) Seed Oil, Rubus Idaeus (Raspberry) Seed Oil, Sambucus Nigra Flower Extract, Sodium Hydroxide, Sodium Phytate, Sorbitan Olivate, Water/Aqua, Xanthan Gum

Package Label.Principal Display Panel

Deep Long-Lasting Temporary Relief of Arthritis Pain, Joint and Muscle Pain

Safe and Effective

Non-Greasy and Odor Free

Art Label (Artpainrelieflabel)

Art Label (Artpainrelieflabel)

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