T-RELIEF- aconitum napellus,arnica montana root, baptisia tinctoria root, atropa belladonna, 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 liquid
MediNatura

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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T-Relief Oral Drop

ACTIVE INGREDIENTS

Each 10 drops contains

Active ingredients Purpose

*Aconitum napellus 3X..............Reduces joint and back pain

*Arnica montana, radix 3X........Reduces joint and back pain

*Arnica montana, radix 6X........Reduces joint and back pain

*Arnica montana, radix 10X......Reduces joint and back pain

*Baptisia tinctoria 2X................Reduces joint pain and muscle pain soreness

*Belladonna 3X.........................Reduces back pain

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

*Calendula officinalis 2X............Relieves pain

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

*Echinacea 2X..........................Relieves pain

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

*Hypericum perforatum 3X.......Relieves pain

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

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

*Symphytum officinale 8X........Relieves joint pain

*Natural Ingredients

USES

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

INACTIVE INGREDIENTS

Ethanol, Purified water

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

WARNINGS

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If symptoms persist or worsen, a health professional should be consulted. Do not use if known sensitivity to T-ReliefTM or any of its ingredients exists.

DIRECTIONS

At first sign of symptoms: Adults and children 12 years and older: 10 drops every ½ to 1 hour until

symptoms lessen, then continue with standard dosage. Do not exceed 120 drops in 24 hours.

For children under 12 years: Consult your health professional.

Standard Dosage: Adults and children 12 years and older: 30 drops per day, taking 10 drops every 4 to 6 hours.

For children under 12 years: Consult your health professional.

If used in children below 18 years for more than 14 days, contact a health professional as these drops contain alcohol.

PURPOSE

Relieves

• Joint Pain

• Back Pain

• Muscular Pain

T-Relief ORal Drop.jpg

T-RELIEF
aconitum napellus,arnica montana root, baptisia tinctoria root, atropa belladonna, 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 liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62795-2005
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	3 [hp_X] in 50 mL
ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327)	ARNICA MONTANA ROOT	3 [hp_X] in 50 mL
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU)	BAPTISIA TINCTORIA ROOT	2 [hp_X] in 50 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	3 [hp_X] in 50 mL
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	2 [hp_X] in 50 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	2 [hp_X] in 50 mL
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX)	ECHINACEA, UNSPECIFIED	2 [hp_X] in 50 mL
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 50 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	3 [hp_X] in 50 mL
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK)	ACHILLEA MILLEFOLIUM	2 [hp_X] in 50 mL
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S)	RUTA GRAVEOLENS FLOWERING TOP	4 [hp_X] in 50 mL
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	8 [hp_X] in 50 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62795-2005-4	1 in 1 CARTON	09/30/2014	11/13/2018
1		50 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/30/2014	11/13/2018

Labeler - MediNatura (079324099)

Name	Address	ID/FEI	Business Operations
Establishment
MediNatura		102783016	manufacture(62795-2005)

Revised: 11/2018

Document Id: 4125e02d-6bf3-41e7-bb2f-f55e035cc056

Set id: 2848f9d2-41e1-4f46-9b62-dc7099601282

Version: 2

Effective Time: 20181113

MediNatura