The following Structured Product Label (SPL) was submitted to the FDA by G M International, Inc. for the product Painmed (NDC 59824-0008). 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, directions, warnings, otc - ask doctor, otc - do not use, otc - ask doctor/pharmacist, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
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
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.
For external use only.
If you are taking any prescription medication or have a serious medical condition, ask a doctor before 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.
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.
Keep out of the reach of children.
Not for pregnant or lactating women, or children under 14.
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.
Water, Ethyl Alcohol, Vegetable Glycerin, Carbomer, Triethanolamine
1-800-228-9850
www.gmipainmed.com
GMI's
Doctor Recommended
PainMed™
Fast - Powerful - Odorless
Homeopathic Pain Relieving External Gel
Net wt 1.5 oz (42.5g)
Principal Display Panel (42.5g Tube Carton)
* Please review the disclaimer below.
