FDA Label for Painmed Homeopathic Pain Relieving External

View Indications, Usage & Precautions

Painmed Homeopathic Pain Relieving External Product Label

The following document was submitted to the FDA by the labeler of this product G M International, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Purpose



For the temporary relief of minor aches and pains of joints and muscles associated with minor injuries, arthritis, rheumatism, sports injuries, bumps, sprains, strains, inflammation, stiff neck, simple backache, discomforts, soreness, bruises, and minor muscle spasms.


Other



DO NOT USE IF TAMPER SEAL IS DISTURBED OR BROKEN.

KEEP AND READ CARTON, IT CONTAINS IMPORTANT INFORMATION.

Dist. by GM International, Inc.
Billings, MT 59102 USA


Directions



Adults, and children 14 years of age or older: Gently apply a small amount by hand to affected area, up to a maximum of 3 to 4 times daily (or every 30 minutes at the start of an injury for the first 2 hours). Do not massage nor apply in direct sunlight. Discontinue use when symptoms are relieved. Not for use by children under 14. Do not use with other topical remedies, ultrasound, electrical, or vibrational therapies.


Warnings



For external use only.


Otc - Ask Doctor



If you are taking any prescription medication or have a serious medical condition, ask a doctor before use.


Otc - Do Not Use



Do not bandage tightly or apply to wounds or damaged skin. Do not get gel into eyes.

Do not apply over large areas of the body. Not for use by persons with allergic sensitivities to Arnica nor any other ingredient.


Otc - Ask Doctor/Pharmacist



If condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days, or if a rash or an allergic reaction develops, stop use and consult your physician.


Otc - Keep Out Of Reach Of Children



Keep out of the reach of children.


Otc - Pregnancy Or Breast Feeding



Not for pregnant or lactating women, or children under 14.


Active Ingredients



Aconitum Napellus 3x, Arnica Montana 3x, 6x, Bellis Perennis 1x, Bryonia Alba 6x, 12x, Calendula Officinalis 1x, Hamamelis Virginiana 2x, Hypericum Perforatum 2x, Ledum Palustre 3x, Ruta Graveolens 3x.


Inactive Ingredients



Water, Ethyl Alcohol, Vegetable Glycerin, Carbomer, Triethanolamine


Otc - Questions



1-800-228-9850

www.gmipainmed.com


Principal Display Panel - 42.5G Tube Carton



GMI's
Doctor Recommended

PainMed™

Fast - Powerful - Odorless

Homeopathic Pain Relieving External Gel
Net wt 1.5 oz (42.5g)


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