PainMed

Manufacturer
G M International, Inc. | Cosmetic Creations Inc.
Effective date
2017-12-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:09:07

Label at a glance#

ProductPainMed Homeopathic Pain Relieving External
Active ingredientACONITUM NAPELLUS, ARNICA MONTANA, BELLIS PERENNIS, BRYONIA ALBA ROOT, CALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, HYPERICUM PERFORATUM, RHODODENDRON TOMENTOSUM LEAFY TWIG, RUTA GRAVEOLENS FLOWERING TOP
Label structure9 sections

Dosage and administration

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 thera...

Label contents#

Full prescribing information#

Indications

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

WARNINGS SECTION

For external use only.

OTC - ASK DOCTOR SECTION

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

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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 SECTION

Keep out of the reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - DO NOT USE SECTION

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

OTC - ACTIVE INGREDIENT SECTION

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

INACTIVE INGREDIENT SECTION

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

PRINCIPAL DISPLAY PANEL - 42.5g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Principal Display Panel - 42.5g Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59824-0008-22020-01-31C16284748780-19d75b9d0-9c8e-f424-e053-dadaa90a57cePainMed™ Homeopathic Pain Relieving External

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59824-0008-2PainMed Homeopathic Pain Relieving External42.5 g in 1 TUBEGEL42.52
59824-0008-2PainMed Homeopathic Pain Relieving External1 in 1 BOXGEL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59824-0008PAINMED 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 [G M INTERNATIONAL, INC.]2Legacy NDC, 2 package rows20171228_cf85b8db-ba3c-4478-9456-90d7adb65286.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACONITUM NAPELLUSACTIVE INGREDIENTU0NQ8555JD1
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZW1
BELLIS PERENNISACTIVE INGREDIENT2HU33I03UY1
BRYONIA ALBA ROOTACTIVE INGREDIENTT7J046YI2B1
CALENDULA OFFICINALIS FLOWERING TOPACTIVE INGREDIENT18E7415PXQ1
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKACTIVE INGREDIENTT7S323PKJS1
HYPERICUM PERFORATUMACTIVE INGREDIENTXK4IUX8MNB1
LEDUM PALUSTRE TWIGACTIVE INGREDIENT877L01IZ0P1
RUTA GRAVEOLENS FLOWERING TOPACTIVE INGREDIENTN94C2U587S1
ACONITUM NAPELLUSACTIVE MOIETYU0NQ8555JD1
ARNICA MONTANAACTIVE MOIETYO80TY208ZW1
BELLIS PERENNISACTIVE MOIETY2HU33I03UY1
BRYONIA ALBA ROOTACTIVE MOIETYT7J046YI2B1
CALENDULA OFFICINALIS FLOWERING TOPACTIVE MOIETY18E7415PXQ1
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKACTIVE MOIETYT7S323PKJS1
HYPERICUM PERFORATUMACTIVE MOIETYXK4IUX8MNB1
LEDUM PALUSTRE TWIGACTIVE MOIETY877L01IZ0P1
RUTA GRAVEOLENS FLOWERING TOPACTIVE MOIETYN94C2U587S1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27E1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59824-000859824-0008-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 165 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKAEROSOL, FOAM / TOPICAL2.6 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ECREAM / TOPICAL103 mgExact identifier — unii candidate
9 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii candidate
75 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSPRAY / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKAEROSOL, METERED / RECTALADJ PHExact identifier — unii candidate
22 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKLIQUID / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSOLUTION / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ECREAM, AUGMENTED / TOPICAL20 mgExact identifier — unii candidate
9 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii candidate
22 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSOAP / TOPICAL0.08 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii candidate
9 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKEMULSION / TOPICAL0.5 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ELOTION / TOPICAL300 mgExact identifier — unii candidate
9 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL, METERED / TRANSDERMAL50 mgExact identifier — unii candidate
9 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bb7f3c11-acfb-4b01-829d-20d77054b54acf85b8db-ba3c-4478-9456-90d7adb652862017-12-27WarningsExact identifier
spl id: bb7f3c11-acfb-4b01-829d-20d77054b54a
spl set id: cf85b8db-ba3c-4478-9456-90d7adb65286

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.