My Pain Away Fibro Cream Drug Facts

Manufacturer
Topical BioMedics, Inc.
Effective date
2014-06-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:06:03

Label at a glance#

ProductMy Pain Away
Active ingredientAESCULUS HIPPOCASTANUM FLOWER, ARNICA MONTANA, ATROPA BELLADONNA, CROTALUS HORRIDUS HORRIDUS VENOM, ECHINACEA ANGUSTIFOLIA, GRAPHITE, HELODERMA HORRIDUM VENOM, LACHESIS MUTA VENOM, NAJA NAJA VENOM, TOXICODENDRON PUBESCENS LEAF, RUTA GRAVEOLENS FLOWERING TOP
Label structure13 sections

Indications and uses

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

Dosage and administration

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).

Storage and handling

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

Label contents#

Full prescribing information#

Homeopathic Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

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

Uses:

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not apply in eyes.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep all medicines out of reach of children.

OTC - STOP USE SECTION

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 SECTION

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

SPL UNCLASSIFIED SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

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:

INACTIVE INGREDIENT SECTION

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:

STORAGE AND HANDLING SECTION

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

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 PanelPrinicpal Display Panel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61500-5587-32020-01-31C16284748780-19d75b9d1-157b-f424-e053-dadaa90a57ceMy Pain Away Fibro Cream Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61500-5587-3My Pain Away88 mL in 1 TUBECREAM881

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61500-5587MY PAIN AWAY (AESCULUS HIPPOCASTANUM, ARNICA MONTANA, BELLADONNA, CROTALUS HORRIDUS, ECHINACEA, GRAPHITES, HELODERMA, LACHESIS MUTUS, NAJA TRIPUDIANS, RHUS TOXICODENDRON, RUTA GRAVEOLENS) CREAM [TOPICAL BIOMEDICS, INC.]1Legacy NDC, 1 package rows20141007_714315cd-573e-47de-9f5c-f482240eb387.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AESCULUS HIPPOCASTANUM FLOWERACTIVE INGREDIENTKK0Z92II8M1
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZW1
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H1
CROTALUS HORRIDUS HORRIDUS VENOMACTIVE INGREDIENTYHA2XLJ9561
ECHINACEA ANGUSTIFOLIAACTIVE INGREDIENTVB06AV5US81
GRAPHITEACTIVE INGREDIENT4QQN74LH4O1
HELODERMA HORRIDUM VENOMACTIVE INGREDIENTO9M1UQ4YIO1
LACHESIS MUTA VENOMACTIVE INGREDIENTVSW71SS07I1
NAJA NAJA VENOMACTIVE INGREDIENTZZ4AG7L7VM1
RUTA GRAVEOLENS FLOWERING TOPACTIVE INGREDIENTN94C2U587S1
TOXICODENDRON PUBESCENS LEAFACTIVE INGREDIENT6IO182RP7A1
AESCULUS HIPPOCASTANUM FLOWERACTIVE MOIETYKK0Z92II8M1
ARNICA MONTANAACTIVE MOIETYO80TY208ZW1
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H1
CROTALUS HORRIDUS HORRIDUS VENOMACTIVE MOIETYYHA2XLJ9561
ECHINACEA ANGUSTIFOLIAACTIVE MOIETYVB06AV5US81
GRAPHITEACTIVE MOIETY4QQN74LH4O1
HELODERMA HORRIDUM VENOMACTIVE MOIETYO9M1UQ4YIO1
LACHESIS MUTA VENOMACTIVE MOIETYVSW71SS07I1
NAJA NAJA VENOMACTIVE MOIETYZZ4AG7L7VM1
RUTA GRAVEOLENS FLOWERING TOPACTIVE MOIETYN94C2U587S1
TOXICODENDRON PUBESCENS LEAFACTIVE MOIETY6IO182RP7A1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
COCONUT ACIDINACTIVE INGREDIENT40U37V505D1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJS1
PALM KERNEL OILINACTIVE INGREDIENTB0S90M02331
QUATERNIUM-15 CIS-FORMINACTIVE INGREDIENTLIT014L4RH1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I1
STEARETH-12INACTIVE INGREDIENT51J36A59E01
SUCROSEINACTIVE INGREDIENTC151H8M5541
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61500-558761500-5587-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 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 6 · 339 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRAVITREALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / NASAL20 mgExact identifier — unii candidate
174 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSLOTION / TOPICAL50 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IOINTMENT, AUGMENTED / TOPICAL0.11 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / SUBCUTANEOUS1 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
COCONUT ACIDCOCONUT ACID40U37V505DSOLUTION / TOPICAL0.7 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL / TOPICAL1.16 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IFILM, EXTENDED RELEASE / TRANSDERMAL0.85 mgExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS308 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICREAM / VAGINAL0.19 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CONCENTRATE / ORAL4800 mgExact identifier — unii candidate
48 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRACAUDALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRASPINALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSUSPENSION / AURICULAR (OTIC)1 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTERSTITIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / VAGINAL200 mgExact identifier — unii candidate
20 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IPASTE / DENTAL0.6 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSSPRAY / TOPICAL3665 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSOIL / AURICULAR (OTIC)36 mgExact identifier — unii candidate
18 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSCREAM / VAGINAL50 mgExact identifier — unii candidate
18 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUPPOSITORY / RECTALNAExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SOLUTION / RECTAL35.42 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS78.36 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / RETROBULBARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / PERIODONTALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, COATED PELLETS / ORAL59.8 mgExact identifier — unii candidate
48 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSAEROSOL, SPRAY / TOPICAL6.89 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IELIXIR / ORALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SUCROSESUCROSEC151H8M554WAFER / ORAL155.2 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICAPSULE, COATED / ORAL0.08 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / TOPICAL39 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILOTION, AUGMENTED / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / SUBCUTANEOUS31.45 mgExact identifier — unii candidate
174 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSOINTMENT / TOPICAL35 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRACARDIACADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRAPLEURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IPOWDER / RESPIRATORY (INHALATION)ADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, COATED / ORAL516.42 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILIQUID / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, DELAYED RELEASE / ORAL955 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / PARENTERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SUCROSESUCROSEC151H8M554LIQUID / ORAL37500 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii candidate
174 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSUSPENSION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
20 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
e77e7b72-847e-48df-93cc-3e20bdd234dd714315cd-573e-47de-9f5c-f482240eb3872014-06-20WarningsExact identifier
spl id: e77e7b72-847e-48df-93cc-3e20bdd234dd
spl set id: 714315cd-573e-47de-9f5c-f482240eb387

Reported adverse events (FAERS/openFDA)#

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