ARNICA WELL- bellis perennis, calendula officinalis, hamamelis virginiana, millefollium mt, chamomilla, ferrum phosphoricum, ledum palustre, magnesia phosphorica, apis mellifica, arnica montana, belladonna, symphytum officinale, hypericum perforatum. gel

Arnica Well by

Drug Labeling and Warnings

Arnica Well by is a Homeopathic medication manufactured, distributed, or labeled by Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics 052584997. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS (HPUS*): Bellis Perennis MT, Calendula Officinalis MT, Hamamelis Virginiana MT, Millefollium MT, Chamomilla 1X, Ferrum Phosphoricum 2X, Ledum Palustre 2X, Magnesia Phosphorica 2X, Apis Mellifica 3X, Arnica Montana 3X, Belladonna 3X, Symphytum Officinale 4X, Hypericum Perforatum 6X.

*The letters "HPUS" indicate that the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.

INDICATIONS & USAGE

USES: Temporarily relieves pain and swelling from contusions, sprains, and hematomas as well as muscle and joint pains.

WARNINGS

WARNINGS:

• FOR TOPICAL USE ONLY.
• DO NOT APPLY ON OPEN WOUNDS.
• Consult a physician for use in children under 12 years of age.
• IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
• IF PAIN PERSISTS, seek the advice of your health care professional.

KEEP OUT OF THE REACH OF CHILDREN.

DOSAGE & ADMINISTRATION

DIRECTIONS: One application several times daily on the skin, rub &/or apply ointment dressing or use as recommended by a Health Care Professional.

OTHER SAFETY INFORMATION

OTHER INFORMATION: TAMPER SEAL: "SEALED FOR YOUR PROTECTION". Do not use if seal is broken or missing.

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Carbomer 940, Glycerin, Organic Aloe Vera Powder, Purified Water, Sodium Hydroxymethylglycinate.

QUESTIONS

QUESTIONS & COMMENTS?: Be Well Homeopathics / www.bewellhomeo.com / 1.877.438.3042

PRINCIPAL DISPLAY PANEL

Be Well Homeopathics

1-877-438-3043

www.bewellhomeo.com

NDC: 66492-069-02

NDC: 66492-069-03

Arnica Well GEL

TOPICAL HOMEOPATHIC

1.75 oz (50 g)

11 oz (330 g)

Pain & Inflammation

INGREDIENTS AND APPEARANCE

ARNICA WELL 
bellis perennis, calendula officinalis, hamamelis virginiana, millefollium mt, chamomilla, ferrum phosphoricum, ledum palustre, magnesia phosphorica, apis mellifica, arnica montana, belladonna, symphytum officinale, hypericum perforatum. gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66492-069
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY)	BELLIS PERENNIS	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
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS)	HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	1 [hp_X]  in 1 g
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK)	ACHILLEA MILLEFOLIUM	1 [hp_X]  in 1 g
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	1 [hp_X]  in 1 g
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7)	FERROSOFERRIC PHOSPHATE	2 [hp_X]  in 1 g
RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P)	RHODODENDRON TOMENTOSUM LEAFY TWIG	2 [hp_X]  in 1 g
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	2 [hp_X]  in 1 g
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	3 [hp_X]  in 1 g
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	3 [hp_X]  in 1 g
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	3 [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
CARBOMER 940 (UNII: 4Q93RCW27E)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66492-069-02	50 g in 1 TUBE; Type 0: Not a Combination Product	08/26/2013
2	NDC: 66492-069-03	330 g in 1 TUBE; Type 0: Not a Combination Product	08/18/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/18/2013

Labeler - Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics 052584997 (052584997)

Registrant - OHM PHARMA INC. (030572478)

Establishment
Name	Address	ID/FEI	Business Operations
OHM PHARMA INC.		030572478	manufacture(66492-069)