PAINMED HOMEOPATHIC PAIN RELIEVING EXTERNAL- aconitum napellus, arnica montana, bellis perennis, bryonia alba root, calendula officinalis flowering top, hamamelis virginiana root bark/stem bark, hypericum perforatum, ledum palustre twig, and ruta graveolens flowering top gel

PainMed by

Drug Labeling and Warnings

PainMed by is a Homeopathic medication manufactured, distributed, or labeled by G M International, Inc., Cosmetic Creations Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Indications

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.

SPL UNCLASSIFIED SECTION

DO NOT USE IF TAMPER SEAL IS DISTURBED OR BROKEN.

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.

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.

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.

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

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

SPL UNCLASSIFIED SECTION

KEEP AND READ CARTON, IT CONTAINS IMPORTANT INFORMATION.

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

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)

INGREDIENTS AND APPEARANCE

PAINMED   HOMEOPATHIC PAIN RELIEVING EXTERNAL
aconitum napellus, arnica montana, bellis perennis, bryonia alba root, calendula officinalis flowering top, hamamelis virginiana root bark/stem bark, hypericum perforatum, ledum palustre twig, and ruta graveolens flowering top gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59824-0008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	3 [hp_X]  in 1 g
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	6 [hp_X]  in 1 g
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY)	BELLIS PERENNIS	1 [hp_X]  in 1 g
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	12 [hp_X]  in 1 g
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	1 [hp_X]  in 1 g
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS)	HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	2 [hp_X]  in 1 g
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	2 [hp_X]  in 1 g
RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (RHODODENDRON TOMENTOSUM LEAFY TWIG - UNII:877L01IZ0P)	RHODODENDRON TOMENTOSUM LEAFY TWIG	3 [hp_X]  in 1 g
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S)	RUTA GRAVEOLENS FLOWERING TOP	3 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59824-0008-2	1 in 1 BOX	08/01/2003
1		42.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved homeopathic		08/01/2003

Labeler - G M International, Inc. (616177916)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Creations Inc.		079375497	MANUFACTURE(59824-0008) , LABEL(59824-0008)