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

T-Relief Extra Strength Cream by

Drug Labeling and Warnings

T-Relief Extra Strength Cream by is a Homeopathic medication manufactured, distributed, or labeled by MediNatura Inc, Medical Products Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INGREDIENTS

Arnica montana 1X 3.3%, Calendula officinalis 1X 2.51%, Echinacea 1X 0.75%, Aconitum napellus 1X 0.08%, Millefolium 2X 2.71%, Hamamelis virginiana 2X 2.26%, Chamomilla 2X 0.91%, Belladonna 2X 0.75%, Bellis perennis 2X 0.75%, Arnica montana 3X 2.51%, Ruta graveolens 4X 3%, Baptisia tinctoria 4X 0.75%, Symphytum officinale 4X 0.15%, Hypericum perforatum 6X 0.12%, Arnica montana 10X 0.12%, Natural Ingredients.

INDICATIONS

Pain Relief

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

USES

For the temporary relief of minor:
Joint Pain
Back Pain
Muscular Pain
Nerve Pain
Arthritis 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 reaction may develop. Do not use if known sensitivity to T-Relief 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 health professional before use.

DIRECTIONS

Twist off cap and remove foil seal. Adults and children 4 and older: Apply generously to affected area 2 to 3 times daily or more often if necessary, as directed by your health professional. Massage thoroughly into the skin. If appropriate, mild compression or occlusive bandaging may be applied. For children under 4, consult your health professional.

INACTIVE INGREDIENT

Organic Aloe Oil, (Organic Aloe Vera Powder, Organic Soybean Oil, Vitamin E) Caprylic/Capric Triglycerides (from Cocos nucifera), Carrageenan (processed Eucheuma seaweed) Organic Coconut Oil, Organic Ethanol, Organic Safflower Oil, Phenoxyethanol,(Preservative), Purified Water, Organic Shea Butter, Sodium Polyacrylate ( Emulsifier), Sunflower Seed Wax.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62795-7007
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
ALOE (UNII: V5VD430YW9)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALCOHOL (UNII: 3K9958V90M)
SAFFLOWER OIL (UNII: 65UEH262IS)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CARRAGEENAN (UNII: 5C69YCD2YJ)
COCONUT OIL (UNII: Q9L0O73W7L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62795-7007-7	1 in 1 CARTON	10/19/2017
1		85 g 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		10/19/2017

Labeler - MediNatura Inc (079324099)

Establishment
Name	Address	ID/FEI	Business Operations
Medical Products Laboratories		002290302	manufacture(62795-7007)