T-RELIEF- aconitum napellus, arnica montana, baptisia tinctoria root, atropa belladonna, bellis perennis, calendula officinalis flowering top, matricaria recutita, echinacea unspecified, hamamelis virginiana root bark stem bark, hypericum perforatum, achillea millefolium, ruta graveolens flowering top and comfrey root gel

T-Relief by

Drug Labeling and Warnings

T-Relief by is a Homeopathic medication manufactured, distributed, or labeled by MediNatura Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Active ingredients                  Purpose

*Aconitum napellus 1X 0.5%................Reduces joint and back pain

*Arnica montana 1X 2%........Reduces joint and back pain

*Arnica montana 3X 2%..........Reduces joint and back pain

*Arnica montana10X 2%........Reduces joint and back pain

*Baptisia tinctoria 4X 1% ..................Reduces joint and muscle pain

*Belladonna 2X 1%...........................Reduces back pain

*Bellis perennis 2X 1%......................Relieves joint and muscle soreness

*Calendula officinalis 1X 1%..............Relieves pain

*Chamomilla 2X 1%.........................Soothing pain relief

*Echinacea 1X 1%............................Relieves pain

*Hamamelis virginiana 2X 2%...........Relieves joint and muscle soreness

*Hypericum perforatum 6X 0.1%.........Relieves pain

*Millefolium 2X 2%...........................Relieves pain

*Ruta graveolens 4X 2%..................Relieves pain

*Symphytum officinale 4X 0.1%..........Relieves joint pain

*Natural Ingredients

USES

For the temporary relief of minor: Joint Pain Back Pain Muscular Pain Nerve Pain

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS

Relieves

Joint Pain

Back Pain

Muscular Pain

Nerve Pain

WARNINGS

 For external use only. Do not apply over open wounds or broken skin. If symptoms persist or worsen, or if a rash develops, a health professional should be consulted. In rare cases, allergic skin reactions may develop. Do not use if known sensitivity to T-ReliefTM or any of its ingredients exists.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use.

DIRECTIONS

Twist off cap and remove the foil seal.

Adults and children 4 years and older: Apply generously to affected areas 2 to 3 times daily, or more often if necessary. Massage thoroughly into the skin. If appropriate, mild compression or occlusive bandaging may be applied.

For children under 4,consult your health professional.

INACTIVE INGREDIENTS

Carbomer 980, Phenoxyethanol, Purified Water, SD Alcohol 3C, Sodium Hydroxide.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

T-RELIEF 
aconitum napellus, arnica montana, baptisia tinctoria root, atropa belladonna, bellis perennis, calendula officinalis flowering top, matricaria recutita, echinacea unspecified, hamamelis virginiana root bark stem bark, hypericum perforatum, achillea millefolium, ruta graveolens flowering top and comfrey root gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62795-7005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	1 [hp_X]  in 1 g
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	1 [hp_X]  in 1 g
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU)	BAPTISIA TINCTORIA ROOT	4 [hp_X]  in 1 g
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	2 [hp_X]  in 1 g
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY)	BELLIS PERENNIS	2 [hp_X]  in 1 g
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	1 [hp_X]  in 1 g
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	2 [hp_X]  in 1 g
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX)	ECHINACEA, UNSPECIFIED	1 [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 BARK	2 [hp_X]  in 1 g
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	6 [hp_X]  in 1 g
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK)	ACHILLEA MILLEFOLIUM	2 [hp_X]  in 1 g
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S)	RUTA GRAVEOLENS FLOWERING TOP	2 [hp_X]  in 1 g
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	4 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62795-7005-6	1 in 1 CARTON	07/31/2016
1		57 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 62795-7005-5	250 g in 1 BOTTLE; Type 0: Not a Combination Product	07/31/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/31/2016

Labeler - MediNatura Inc (079324099)

Establishment
Name	Address	ID/FEI	Business Operations
Medical Products Laboratories		002290302	manufacture(62795-7005)