Label: 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
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Contains inactivated NDC Code(s)
NDC Code(s): 61500-1501-6 - Packager: Topical BioMedics, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated February 5, 2016
If you are a consumer or patient please visit this version.
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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
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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.
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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
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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).
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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.
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INGREDIENTS AND APPEARANCE
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 creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61500-1501 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AESCULUS HIPPOCASTANUM BARK (UNII: 7U76MXL14N) (AESCULUS HIPPOCASTANUM BARK - UNII:7U76MXL14N) AESCULUS HIPPOCASTANUM BARK 6 [hp_X] in 1 [hp_X] ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 6 [hp_X] in 1 [hp_X] BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS 6 [hp_X] in 1 [hp_X] CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H) (CALENDULA OFFICINALIS WHOLE - UNII:PFR03EBU0H) CALENDULA OFFICINALIS WHOLE 6 [hp_X] in 1 [hp_X] SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 8 [hp_X] in 1 [hp_X] CAPSICUM ANNUUM WHOLE (UNII: 7FKZ3QQQ1F) (CAPSICUM ANNUUM WHOLE - UNII:7FKZ3QQQ1F) CAPSICUM ANNUUM WHOLE 10 [hp_X] in 1 [hp_X] CROTALUS HORRIDUS HORRIDUS WHOLE (UNII: EX19F9NWH9) (CROTALUS HORRIDUS HORRIDUS WHOLE - UNII:EX19F9NWH9) CROTALUS HORRIDUS HORRIDUS WHOLE 8 [hp_X] in 1 [hp_X] ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED 6 [hp_X] in 1 [hp_X] GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE 6 [hp_X] in 1 [hp_X] GELSEMIUM SEMPERVIRENS WHOLE (UNII: R0519OZO3K) (GELSEMIUM SEMPERVIRENS WHOLE - UNII:R0519OZO3K) GELSEMIUM SEMPERVIRENS WHOLE 8 [hp_X] in 1 [hp_X] HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 6 [hp_X] in 1 [hp_X] LACHESIS MUTA WHOLE (UNII: 6Y582I290C) (LACHESIS MUTA WHOLE - UNII:6Y582I290C) LACHESIS MUTA WHOLE 8 [hp_X] in 1 [hp_X] POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE 8 [hp_X] in 1 [hp_X] MAGNESIUM PHOSPHATE, MONOBASIC, UNSPECIFIED (UNII: W30T5D628Q) (MAGNESIUM PHOSPHATE, MONOBASIC, UNSPECIFIED - UNII:W30T5D628Q) MAGNESIUM PHOSPHATE, MONOBASIC, UNSPECIFIED 6 [hp_X] in 1 [hp_X] NAJA NAJA WHOLE (UNII: D279BDR31E) (NAJA NAJA WHOLE - UNII:D279BDR31E) NAJA NAJA WHOLE 8 [hp_X] in 1 [hp_X] RHUS SPP. WHOLE (UNII: 3U7FG9T9MW) (RHUS SPP. WHOLE - UNII:3U7FG9T9MW) RHUS SPP. WHOLE 12 [hp_X] in 1 [hp_X] RUTA GRAVEOLENS WHOLE (UNII: 181JI0338P) (RUTA GRAVEOLENS WHOLE - UNII:181JI0338P) RUTA GRAVEOLENS WHOLE 6 [hp_X] in 1 [hp_X] Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:61500-1501-6 1 in 1 CARTON 04/01/2016 1 1 [hp_X] 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 04/01/2016 Labeler - Topical BioMedics, Inc. (125911037) Establishment Name Address ID/FEI Business Operations Ultra-tab Laboratories, Inc. 151051757 manufacture(61500-1501)