MY PAIN AWAY - aesculus hippocastanum, arnica montana, belladonna, crotalus horridus, echinacea, graphites, heloderma, lachesis mutus, naja tripudians, rhus toxicodendron, ruta graveolens cream 
Topical BioMedics, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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My Pain Away Fibro Cream

Drug Facts

Homeopathic Active Ingredients:

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:

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

Warnings

For external use only

Do not apply in eyes.

Keep all medicines out of reach of children.

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.

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

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

Directions:

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:

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:

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

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

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 Panel

MY PAIN AWAY 
aesculus hippocastanum, arnica montana, belladonna, crotalus horridus, echinacea, graphites, heloderma, lachesis mutus, naja tripudians, rhus toxicodendron, ruta graveolens cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61500-5587
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (AESCULUS HIPPOCASTANUM FLOWER - UNII:KK0Z92II8M) AESCULUS HIPPOCASTANUM FLOWER6 [hp_X]  in 88 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA6 [hp_X]  in 88 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA6 [hp_X]  in 88 mL
CROTALUS HORRIDUS HORRIDUS VENOM (UNII: YHA2XLJ956) (CROTALUS HORRIDUS HORRIDUS VENOM - UNII:YHA2XLJ956) CROTALUS HORRIDUS HORRIDUS VENOM8 [hp_X]  in 88 mL
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA 6 [hp_X]  in 88 mL
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE6 [hp_X]  in 88 mL
HELODERMA HORRIDUM VENOM (UNII: O9M1UQ4YIO) (HELODERMA HORRIDUM VENOM - UNII:O9M1UQ4YIO) HELODERMA HORRIDUM VENOM8 [hp_X]  in 88 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM8 [hp_X]  in 88 mL
NAJA NAJA VENOM (UNII: ZZ4AG7L7VM) (NAJA NAJA VENOM - UNII:ZZ4AG7L7VM) NAJA NAJA VENOM8 [hp_X]  in 88 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF6 [hp_X]  in 88 mL
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP6 [hp_X]  in 88 mL
Inactive Ingredients
Ingredient NameStrength
COCONUT ACID (UNII: 40U37V505D)  
SUCROSE (UNII: C151H8M554)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
QUATERNIUM-15 CIS-FORM (UNII: LIT014L4RH)  
GLYCERIN (UNII: PDC6A3C0OX)  
PALM KERNEL OIL (UNII: B0S90M0233)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
STEARETH-12 (UNII: 51J36A59E0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61500-5587-388 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/01/2014
Labeler - Topical BioMedics, Inc. (125911037)

Revised: 6/2014
Document Id: e77e7b72-847e-48df-93cc-3e20bdd234dd
Set id: 714315cd-573e-47de-9f5c-f482240eb387
Version: 1
Effective Time: 20140620
 
Topical BioMedics, Inc.