My Pain Away
FDA Label NDC 61500-5587

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topical Biomedics, Inc. for the product My Pain Away (NDC 61500-5587). 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 homeopathic active ingredients:, otc - purpose, uses:, warnings, otc - do not use, otc - keep out of reach of children, otc - stop use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Homeopathic Active Ingredients:

Aesculus hippocastanum 6X, Arnica montana 6X, Belladonna 6X, Crotalus horridus 8X, Echinacea 6X, Graphites 6X, Heloderma 8X, Lachesis mutus 8X, Naja tripudians 8X, Rhus toxicodendron 6X, Ruta graveolens 6X

Otc - Purpose


Uses:

Rapid soothing relief of muscle pain at tender points or nerve pain associated with Fibromyalgia and Neuropathy.

Warnings

For external use only

Otc - Do Not Use

Do not apply in eyes.

Otc - Keep Out Of Reach Of Children

Keep all medicines out of reach of children.

Otc - Stop Use

Use only as directed, see doctor if pain last more than 3 days, new symptoms occur, redness or swelling could indicate a more serious condition.

Otc - Ask Doctor

Always consult a doctor before beginning a self-help regimen if you are taking a prescription medicine.

Other

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Generously apply 3-4 times daily or more often if needed, 3 inches on and around affected area. Massage in until absorbed, reapply before bedtime and in the morning. Use before and after physical activity. Apply immediately for acute trauma injuries (sprain, strain, bruise and impact injuries).

Inactive Ingredients:

Captex 300 (from coconut fatty acids), Carbopol® Ultrez 10 (from sucrose), Cetyl Alcohol (from coconut oil), Dowicil, Glycerine (Vegetable-based), Hydrokote (palm kernal oil with lecithin), Isopropyl Myristate emollient (from palm seeds), Lipomulse (from coconut fatty acids), Purified Water, Sodium hydroxide, Steareth-12 (from stearic acid cocoa butter)

Other Information:

Store at 15° to 30°C (59° to 86°F). Tamper Evident: Do not use if tube is punctured, cut or opened.

Otc - Questions

Formulated by: Topical BioMedics, Inc.

Rhinebeck, NY 12572 1-845-871-4900

MyPainAway™ Fibro Cream is a registered trademark of Topical BioMedics, Inc.

www.mypoinawayfibrocream.com

Principal Display Panel 3 Oz

Homeopathic

Contains Arnica

MyPainAway™

Fibro Cream

To Relieve Pains Assoicated with Fibromyalgia and Neuropathy

3% of all Fibro Cream sales donated to Fibromyalgia Research Foundations

Powerd by Topricin®

Prinicpal Display Panel (Mypainaway 01)

Prinicpal Display Panel (Mypainaway 01)

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