Search by Drug Name or NDC

NDC 66492-0069-02 Arnica Well 1; 3; 3; 3; 1; 1; 4; 2; 1; 6; 2; 1; 2 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Details

Arnica Well 1; 3; 3; 3; 1; 1; 4; 2; 1; 6; 2; 1; 2 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g

Arnica Well is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics 052584997. The primary component is ACHILLEA MILLEFOLIUM; APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; FERROSOFERRIC PHOSPHATE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBA.

Product Information

NDC	66492-0069
Product ID	66492-069_d44a0c64-228a-9c8f-e053-2a95a90a2bbf
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Arnica Well
Proprietary Name Suffix	n/a
Non-Proprietary Name	Bellis Perennis, Calendula Officinalis, Hamamelis Virginiana, Millefollium MT, Chamomilla, Ferrum Phosphoricum, Ledum Palustre, Magnesia Phosphorica, Apis Mellifica, Arnica Montana, Belladonna, Symphytum Officinale, Hypericum Perforatum.
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	1; 3; 3; 3; 1; 1; 4; 2; 1; 6; 2; 1; 2
Active Ingredient Units	[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
Substance Name	ACHILLEA MILLEFOLIUM; APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; FERROSOFERRIC PHOSPHATE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBA
Labeler Name	Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics 052584997
Pharmaceutical Class	Allergens [CS], Bee Venoms [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorpti
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 66492-0069-02 (66492006902)

Pricing Information	N/A
NDC Package Code	66492-069-02
Billing NDC	66492006902
Package	50 g in 1 TUBE (66492-069-02)
Marketing Start Date	2013-08-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 52647581-e65c-4f43-bb61-600174bc8e7e Details

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
CARBOMER 940 (UNII: 4Q93RCW27E)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		08/18/2013

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

Revised: 12/2021

Document Id: d44a0c64-228a-9c8f-e053-2a95a90a2bbf

Set id: 52647581-e65c-4f43-bb61-600174bc8e7e

Version: 4

Effective Time: 20211229

Search by Drug Name or NDC

NDC 66492-0069-02 Arnica Well 1; 3; 3; 3; 1; 1; 4; 2; 1; 6; 2; 1; 2 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Details

Arnica Well 1; 3; 3; 3; 1; 1; 4; 2; 1; 6; 2; 1; 2 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g

Product Information

Package

Package Images

NDC 66492-0069-02 (66492006902)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 52647581-e65c-4f43-bb61-600174bc8e7e Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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