Traumex®

Traumex®

Drug Labeling and Warnings

Drug Details

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TRAUMEX- aconitum napellus, arnica montana, atropa belladonna, bellis perennis, bryonia alba root, calendula officinalis flowering top, black cohosh, echinacea angustifolia, hamamelis virginiana root bark/stem bark, hypericum perforatum, and toxicodendron pubescens leaf ointment 
Hyland's

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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Traumex®

Drug Facts

Active ingredientsPurpose
"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Aconitum Napellus 3X HPUSpain in neck, back, shoulders and minor pain in joints
Arnica Montana 3X HPUSpain, stiffness and soreness
Belladonna 6X HPUS (0.0000003% Alkaloids, calculated)stiffness in neck, back, shoulders and joints
Bellis Perennis 6X HPUSmuscle soreness
Bryonia 3X HPUSminor pain and stiffness in joints
Calendula Officinalis 3X HPUSminor pain and presssure in joints
Cimicifuga Racemosa 6X HPUSminor pain in hips and joints
Echinacea Angustifolia 3X HPUSpain in neck, shoulders and fingers
Hamamelis Virginiana 3X HPUSsoreness in muscles and joints
Hypericum Perforatum 3X HPUSaching pain in back, minor joint pain
Rhus Toxicodendron 6X HPUSstiffness and tenderness in knee joint

Uses

Temporarily relieves symptoms of pain and stiffness in neck, back, shoulders and joints: soreness, stiffness and pressure in joints: pain in fingers and hips; stiffness in knee joint; muscle soreness.

Warnings

  • For external use only
  • Do not use if tube seal is broken or missing

Stop use and ask a doctor if

  • symptoms persist for more than 7 days or worsen
  • rash develops

Do not use if known sensitivity to Traumex® or any of its ingredients exists.

If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children. In case of emergency, get medical help, or contact a Poison Control Center immediately.

Directions

Adults and children 6 years and over: Apply liberally to affected area 3 times daily, or as needed, until relieved.

Inactive ingredients

Beeswax, Cetearyl Alcohol, Citric Acid, Potassium Sorbate, Purified Water, Sodium Benzoate, Sodium Stearoyl Glutamate, Vegetable Glycerine, Vegetable Oil, Wintergreen Extract, Xanthan Gum.

Other Information

Hyland's may be contacted for emergency information about our products 24 hours a day, 7 days a week at (800) 624-9659.

PRINCIPAL DISPLAY PANEL - 50 g Tube Carton

NDC: 54973-3204-1
HOMEOPATHIC

SINCE 1903
Hyland's

Traumex®
PAIN RELIEF*

Targeted, Effective Relief of:
Back Pain
Muscle Pain
Minor Joint Pain

1.76 OZ (50 g) OINTMENT

PRINCIPAL DISPLAY PANEL - 50 g Tube Carton
TRAUMEX 
aconitum napellus, arnica montana, atropa belladonna, bellis perennis, bryonia alba root, calendula officinalis flowering top, black cohosh, echinacea angustifolia, hamamelis virginiana root bark/stem bark, hypericum perforatum, and toxicodendron pubescens leaf ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 54973-3204
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS3 [hp_X]  in 1 g
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA3 [hp_X]  in 1 g
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA6 [hp_X]  in 1 g
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS6 [hp_X]  in 1 g
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT3 [hp_X]  in 1 g
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP3 [hp_X]  in 1 g
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH6 [hp_X]  in 1 g
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA3 [hp_X]  in 1 g
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK3 [hp_X]  in 1 g
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM3 [hp_X]  in 1 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF6 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Sodium Stearoyl Glutamate (UNII: 65A9F4P024)  
GLYCERIN (UNII: PDC6A3C0OX)  
CORN OIL (UNII: 8470G57WFM)  
GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)  
Xanthan Gum (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 54973-3204-11 in 1 CARTON
150 g in 1 TUBE; Type 0: Not a Combination Product
2NDC: 54973-3204-210 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED HOMEOPATHIC05/22/2015
Labeler - Hyland's (028570695)
Establishment
NameAddressID/FEIBusiness Operations
Standard Homeopathic Company008316655MANUFACTURE(54973-3204) , PACK(54973-3204)
Establishment
NameAddressID/FEIBusiness Operations
Lifetech Resources622559110MANUFACTURE(54973-3204) , PACK(54973-3204)

Revised: 9/2015
 
Hyland's


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