Arthritic 4431P-dis

Drug Labeling and Warnings

Drug Details [pdf]

ARTHRITIC - JOINT CARE- aconitum nap., apis mel., arnica, arsenicum alb., belladonna, benzoicum acidum,bryonia, calc. carb., chamomilla, cinchona, colchicum, eupatorium perf., gaultheria procumbens, guaiacum, iodium, kali bic., kalmia, ledum,pulsatilla, rhus xicodendron, ruta, sabina, strychninum, uricum acidum, lappa, phytolacca, symphytum, pellet 
Newton Laboratories, Inc.

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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Arthritic 4431P-dis

INDICATIONS & USAGE SECTION

Arthritic - Joint Care   Formulated for symptoms associated with arthritis, uric acid build-up, fibromyalgia, gout, rheumatism and other inflammatory conditions.

DOSAGE & ADMINISTRATION SECTION

Directions:   Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a healthcare professional.  Under age 2, crush or dissolve pellets in purified water.

ACTIVE INGREDIENT SECTION

Aconitum nap. 15x, Apis mel. 15x, Arnica15x, Arsenicum alb. 15x, Belladonna 15x, Benzoicum acidum 15x,Bryonia 15x, Calc. carb. 15x, Chamomilla 15x, Cinchona 15x,Colchicum 15x, Eupatorium perf. 15x, Gaultheria procumbens 15x,Guaiacum 15x, Iodium 15x, Kali bic. 15x, Kalmia 15x, Ledum 15x,Pulsatilla 15x, Rhus toxicodendron 15x, Ruta 15x, Sabina 15x,Strychninum 15x, Uricum acidum 15x, Lappa 3x, Phytolacca 3x,Symphytum 3x.

PURPOSE SECTION

Formulated for symptoms associated with arthritis, uric acid build-up, fibromyalgia, gout, rheumatism and other inflammatory conditions.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.        

QUESTIONS? SECTION

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256   

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.   

PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days

KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

package label

ARTHRITIC - JOINT CARE 
aconitum nap., apis mel., arnica, arsenicum alb., belladonna, benzoicum acidum,bryonia, calc. carb., chamomilla, cinchona, colchicum, eupatorium perf., gaultheria procumbens, guaiacum, iodium, kali bic., kalmia, ledum,pulsatilla, rhus xicodendron, ruta, sabina, strychninum, uricum acidum, lappa, phytolacca, symphytum, pellet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 55714-4431
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS15 [hp_X]  in 1 g
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA15 [hp_X]  in 1 g
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA15 [hp_X]  in 1 g
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE15 [hp_X]  in 1 g
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA15 [hp_X]  in 1 g
BENZOIC ACID (UNII: 8SKN0B0MIM) (BENZOIC ACID - UNII:8SKN0B0MIM) BENZOIC ACID15 [hp_X]  in 1 g
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT15 [hp_X]  in 1 g
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE15 [hp_X]  in 1 g
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA15 [hp_X]  in 1 g
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK15 [hp_X]  in 1 g
COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6) COLCHICUM AUTUMNALE BULB15 [hp_X]  in 1 g
EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP15 [hp_X]  in 1 g
GAULTHERIA PROCUMBENS TOP (UNII: 830295X963) (GAULTHERIA PROCUMBENS TOP - UNII:830295X963) GAULTHERIA PROCUMBENS TOP15 [hp_X]  in 1 g
GUAIAC (UNII: 03C8A0DFJ8) (GUAIAC - UNII:03C8A0DFJ8) GUAIAC15 [hp_X]  in 1 g
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE15 [hp_X]  in 1 g
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE15 [hp_X]  in 1 g
KALMIA LATIFOLIA LEAF (UNII: 79N6542N18) (KALMIA LATIFOLIA LEAF - UNII:79N6542N18) KALMIA LATIFOLIA LEAF15 [hp_X]  in 1 g
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG15 [hp_X]  in 1 g
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS15 [hp_X]  in 1 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF15 [hp_X]  in 1 g
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP15 [hp_X]  in 1 g
JUNIPERUS SABINA LEAFY TWIG (UNII: Z5BEX9K2G1) (JUNIPERUS SABINA LEAFY TWIG - UNII:Z5BEX9K2G1) JUNIPERUS SABINA LEAFY TWIG15 [hp_X]  in 1 g
STRYCHNINE (UNII: H9Y79VD43J) (STRYCHNINE - UNII:H9Y79VD43J) STRYCHNINE15 [hp_X]  in 1 g
URIC ACID (UNII: 268B43MJ25) (URIC ACID - UNII:268B43MJ25) URIC ACID15 [hp_X]  in 1 g
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) (ARCTIUM LAPPA ROOT - UNII:597E9BI3Z3) ARCTIUM LAPPA ROOT3 [hp_X]  in 1 g
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT3 [hp_X]  in 1 g
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT3 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55714-4431-128.35 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/01/201101/31/2019
2NDC: 55714-4431-256.7 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/01/201101/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/01/201101/31/2019
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610manufacture(55714-4431)

Revised: 11/2019