ARTHRITIS CARE- colchicum autumnale, propolis, kalmia latifolia, bryonia, causticum, kali carbonicum, ledum palustre, rhododendron chrysanthum, gel
MedCare Group LLC

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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DRUG FACTS:

ACTIVE INGREDIENTS:

Colchicum Autumnale 6X, Propolis 6X, Kalmia Latifolia 6X, 30X, Bryonia 12X, 30X, Causticum 12X, 30X, Kali Carbonicum 12X, 30X, Ledum Palustre 12X, 30X, Rhododendron Chrysanthum 12X, 30X, Rhus Toxicodendron 12X, 30X, Thuja Occidentalis 12X, 30X.

INDICATIONS:

For temporary relief of pain and stiffness due to arthritis.

WARNINGS:

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

For topical use only.

STORAGE:

Store in a cool, dry place.

DIRECTIONS:

Apply a small amount topically 4 to 6 times daily.

INACTIVE INGREDIENTS:

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS:

For temporary relief of pain and stiffness due to arthritis.

QUESTIONS:

Dist. By: MedCare Group

Boothwyn, PA 19060

302-260-3111

www.medcaregroups.com

PACKAGE DISPLAY LABEL:

MedCare

Arthritis Care

HOMEOPATHIC

Net Wt. 2 OZ

image description

ARTHRITIS CARE
colchicum autumnale, propolis, kalmia latifolia, bryonia, causticum, kali carbonicum, ledum palustre, rhododendron chrysanthum, gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54557-0001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6)	COLCHICUM AUTUMNALE BULB	6 [hp_X] in 1 mL
PROPOLIS WAX (UNII: 6Y8XYV2NOF) (PROPOLIS WAX - UNII:6Y8XYV2NOF)	PROPOLIS WAX	6 [hp_X] in 1 mL
KALMIA LATIFOLIA LEAF (UNII: 79N6542N18) (KALMIA LATIFOLIA LEAF - UNII:79N6542N18)	KALMIA LATIFOLIA LEAF	6 [hp_X] in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	6 [hp_X] in 1 mL
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU)	CAUSTICUM	12 [hp_X] in 1 mL
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D)	POTASSIUM CARBONATE	12 [hp_X] in 1 mL
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P)	LEDUM PALUSTRE TWIG	12 [hp_X] in 1 mL
RHODODENDRON AUREUM LEAF (UNII: IV92NQJ73U) (RHODODENDRON AUREUM LEAF - UNII:IV92NQJ73U)	RHODODENDRON AUREUM LEAF	12 [hp_X] in 1 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	12 [hp_X] in 1 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	12 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)
TROMETHAMINE (UNII: 023C2WHX2V)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54557-0001-1	60 mL in 1 TUBE; Type 0: Not a Combination Product	08/09/2013	05/25/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		08/09/2013	05/25/2018

Labeler - MedCare Group LLC (038668689)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(54557-0001) , api manufacture(54557-0001) , label(54557-0001) , pack(54557-0001)

Revised: 5/2018

Document Id: 51e1a1a7-97b2-4a2c-86df-51abaff17a7f

Set id: 45de500c-5eb6-4f90-a9f5-190613f8995a

Version: 2

Effective Time: 20180525

MedCare Group LLC