MYPAINAWAY SPORTS CREAM- aesculus hippocastanum, arnica montana, bellis perennis, calendula officinalis, capsicum annum, crotalus horridus, echinacea, gelsemium sempervirens, graphites, hypericum perforatum, kali carbonicum, lachesis mutus, magnesium phosphorica, naja tripudians, rhus tox, ruta graveolens, sulphur 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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MyPainAway Sports Cream 6 oz.

Drug Facts - Active Ingredients Section with Purpose

Active Ingredients:Purpose
Aesculus Hippocastanum 6X . . . .For lower back pain, bruising injuries to hip and spine, muscle and joint impact pain
Arnica Montana 6X . . . . . .Relieves muscle and joint impact pain
Bellis Perennis 6X . . . . . .For bruises to nerves, muscle soreness & sprains
Calendula Officinalis 6X . . . . .Promotes rapid healing of chapped, dry, irritated skin
Capsicum Annum 10X. . . . . .Teats muscle spasms and sciatica
Crotalus Horridus 8X . . . . .Relief of swelling impact injury & deep tissue bruising
Echinacea 6X . . . . .Helps detoxify pain site of excess fluids
Gelsemium Sempervirens 8X . . . .For muscle cramps & fatigue
Graphites 6X . . . . .Treats and prevents skin onditions & scarring
Hypericum Perforatum 6X . . . .For nerve injuries, burning pain and trauma injuries
Kali Carbonicum 8X . . . .Treats sharp tearing pain in nerves, muscles and relaxes muscle tension
Lachesis Mutus 8X . . . . .Relieves sudden sharp pain in joints & muscles
Magnesium Phosphorica 6X . . . .Treats muscle cramps and weakness
Naja Tripudians 8X . . . .Relieves pain of nerve inuries and swelling
Rhus Tox 12X . . . . .For burning pain, muscle tension, joint pain and stiffness
Ruta Graveolens 6X . . . .Relieves pain, soreness and bruising of the hands, wrists and shoulders
Sulphur 8X . . . . .Relieves inching, cracked skin, rashes & blisters

Purpose

For lower back pain, bruising injuries to hip and spine, muscle and joint impact pain

Relieves muscle and joint impact pain

For bruises to nerves, muscle soreness & sprains

Promotes rapid healing of chapped, dry, irritated skin

Teats muscle spasms and sciatica

Relief of swelling impact injury & deep tissue bruising

Helps detoxify pain site of excess fluids

For muscle cramps & fatigue

Treats and prevents skin onditions & scarring

For nerve injuries, burning pain and trauma injuries

Treats sharp tearing pain in nerves, muscles and relaxes muscle tension

Relieves sudden sharp pain in joints & muscles

Treats muscle cramps and weakness

Relieves pain of nerve inuries and swelling

For burning pain, muscle tension, joint pain and stiffness

Relieves pain, soreness and bruising of the hands, wrists and shoulders

Relieves inching, cracked skin, rashes & blisters

Uses

Uses: Rapid, soothing relief of • pain • stiffness •tingling or burning nerve pain • Sports injuries • muscle pulls and soreness • impact injuries • sprains • dislocations • repetitive motion injuries: • bursitis • tendonitis • sciatica

Warnings

Warnings: Use only as directed • For external use only • Do not apply in eyes.

Ask a doctor or pharmacist if • pain lasts more than 3 days • new symptoms occur • redness or swelling could indiate a more serious condition

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

KEEP OUT OF REACH OF CHILDREN.

If swallowed, seek professional assistance and contact a Poison Control Center right away.

Inactive Ingredients

Captex 300 (from coconut fatty acids); Carbopol® Ultrez 10 (from sucrose); Cetyl Alcohol (from coconut oil); Spectrastat G 2 (derived from coconut); Glycerine (vegetable-based); Hydrokote (palm kernel oil with lecithin); Isopropyl Myristate emollient (from palm seeds); Lipomulse (from coconut fatty acids); Purified Water; Sodium hydroxide; Steareth-21 (from stearic acid cocoa butter)

Other Information

Store at 15° to 30° C (59° to 86° F). Tamper Evident. Do not use if seal is broken or tube is open. If not completely satisfied within 30 days, return to the point of purchase with receipt for a full refund.

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).

Principal Display Panel

NDC# 61500-1501-6

Homeopathic

contains arnica & more

Patent Pending Formula

MyPainAway(r)

SPORTS

CREAM

CHANGING THE WAY WE TREAT PAIN

MOISTURINZING NATURAL PAIN RELIEF FOR

ATHLETES

WEEKEND WARRIORS

ACTIVE PEOPLE EVERYWHERE

HEAL AND RECOVER FASTER

MORE PRODUCTIVE

WORKOUTS

Powered by Topricin(r)

Net wt. 6 oz.

Principal Display Panel

MYPAINAWAY SPORTS CREAM 
aesculus hippocastanum, arnica montana, bellis perennis, calendula officinalis, capsicum annum, crotalus horridus, echinacea, gelsemium sempervirens, graphites, hypericum perforatum, kali carbonicum, lachesis mutus, magnesium phosphorica, naja tripudians, rhus tox, ruta graveolens, sulphur cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61500-1501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AESCULUS HIPPOCASTANUM BARK (UNII: 7U76MXL14N) (AESCULUS HIPPOCASTANUM BARK - UNII:7U76MXL14N) AESCULUS HIPPOCASTANUM BARK6 [hp_X]  in 1 [hp_X]
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA6 [hp_X]  in 1 [hp_X]
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS6 [hp_X]  in 1 [hp_X]
CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H) (CALENDULA OFFICINALIS WHOLE - UNII:PFR03EBU0H) CALENDULA OFFICINALIS WHOLE6 [hp_X]  in 1 [hp_X]
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR8 [hp_X]  in 1 [hp_X]
CAPSICUM ANNUUM WHOLE (UNII: 7FKZ3QQQ1F) (CAPSICUM ANNUUM WHOLE - UNII:7FKZ3QQQ1F) CAPSICUM ANNUUM WHOLE10 [hp_X]  in 1 [hp_X]
CROTALUS HORRIDUS HORRIDUS WHOLE (UNII: EX19F9NWH9) (CROTALUS HORRIDUS HORRIDUS WHOLE - UNII:EX19F9NWH9) CROTALUS HORRIDUS HORRIDUS WHOLE8 [hp_X]  in 1 [hp_X]
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED6 [hp_X]  in 1 [hp_X]
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE6 [hp_X]  in 1 [hp_X]
GELSEMIUM SEMPERVIRENS WHOLE (UNII: R0519OZO3K) (GELSEMIUM SEMPERVIRENS WHOLE - UNII:R0519OZO3K) GELSEMIUM SEMPERVIRENS WHOLE8 [hp_X]  in 1 [hp_X]
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM6 [hp_X]  in 1 [hp_X]
LACHESIS MUTA WHOLE (UNII: 6Y582I290C) (LACHESIS MUTA WHOLE - UNII:6Y582I290C) LACHESIS MUTA WHOLE8 [hp_X]  in 1 [hp_X]
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE8 [hp_X]  in 1 [hp_X]
MAGNESIUM PHOSPHATE, MONOBASIC, UNSPECIFIED (UNII: W30T5D628Q) (MAGNESIUM PHOSPHATE, MONOBASIC, UNSPECIFIED - UNII:W30T5D628Q) MAGNESIUM PHOSPHATE, MONOBASIC, UNSPECIFIED6 [hp_X]  in 1 [hp_X]
NAJA NAJA WHOLE (UNII: D279BDR31E) (NAJA NAJA WHOLE - UNII:D279BDR31E) NAJA NAJA WHOLE8 [hp_X]  in 1 [hp_X]
RHUS SPP. WHOLE (UNII: 3U7FG9T9MW) (RHUS SPP. WHOLE - UNII:3U7FG9T9MW) RHUS SPP. WHOLE12 [hp_X]  in 1 [hp_X]
RUTA GRAVEOLENS WHOLE (UNII: 181JI0338P) (RUTA GRAVEOLENS WHOLE - UNII:181JI0338P) RUTA GRAVEOLENS WHOLE6 [hp_X]  in 1 [hp_X]
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
PALM KERNEL OIL (UNII: B0S90M0233)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
STEARETH-21 (UNII: 53J3F32P58)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
CETEARETH-12 (UNII: 7V4MR24V5P)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61500-1501-61 in 1 CARTON04/01/2016
11 [hp_X] in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/01/2016
Labeler - Topical BioMedics, Inc. (125911037)
Establishment
NameAddressID/FEIBusiness Operations
Ultra-tab Laboratories, Inc.151051757manufacture(61500-1501)

Revised: 2/2016
Document Id: 2b070b9f-f50f-278e-e054-00144ff8d46c
Set id: 2b070b9f-f50e-278e-e054-00144ff8d46c
Version: 1
Effective Time: 20160205
 
Topical BioMedics, Inc.