Prime 2624L

Drug Labeling and Warnings

Drug Details [pdf]

PRIME OF LIFE- agnus, allium sativum, ambra, angelica sinensis radix , aralia quinquefolia, arnica , arsenicum alb., avena, baptisia, baryta carb., bryonia, cantharis, lachesis, lycopodium, nux vom., phosphoricum ac., pulsatilla, ruta, sabal, selenium, zinc.met.,ginkgo liquid 
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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Prime 2624L

INDICATIONS & USAGE SECTION

Prime of Life    Formulated for symptoms associated with cognitive impairment, muscular atrophy, arthritis, impotence and other aging-related, degenerative conditions.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL. Adults, take 6 drops orally one to four times daily or as directed by a healthcare professional.

ACTIVE INGREDIENT SECTION

Agnus 15x, Allium sativum 15x, Ambra 15x, Angelica sinensis radix 15x, Aralia quinquefolia 15x, Arnica 15x, Arsenicum alb. 15x, Avena 15x, Baptisia 15x, Baryta carb. 15x, Bryonia 15x, Cantharis 15x, Lachesis 15x, Lycopodium 15x, Nux vom.15x, Phosphoricum ac. 15x, Pulsatilla 15x, Ruta 15x, Sabal 15x, Selenium 15x, Zinc. met. 15x, Ginkgo 8x, Ruta 8x, Ginkgo 3x, Ruta 3x.

PURPOSE SECTION

Formulated for symptoms associated with cognitive impairment, muscular atrophy, arthritis, impotence and other aging-related, degenerative conditions.

INACTIVE INGREDIENT SECTION

USP Purified water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.

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

PRIME OF LIFE 
agnus, allium sativum, ambra, angelica sinensis radix , aralia quinquefolia, arnica , arsenicum alb., avena, baptisia, baryta carb., bryonia, cantharis, lachesis, lycopodium, nux vom., phosphoricum ac., pulsatilla, ruta, sabal, selenium, zinc.met.,ginkgo liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 55714-4624
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHASTE TREE (UNII: 433OSF3U8A) (CHASTE TREE - UNII:433OSF3U8A)	CHASTE TREE	15 [hp_X]  in 1 mL
GARLIC (UNII: V1V998DC17) (GARLIC - UNII:V1V998DC17)	GARLIC	15 [hp_X]  in 1 mL
AMBERGRIS (UNII: XTC0D02P6C) (AMBERGRIS - UNII:XTC0D02P6C)	AMBERGRIS	15 [hp_X]  in 1 mL
ANGELICA SINENSIS ROOT (UNII: B66F4574UG) (ANGELICA SINENSIS ROOT - UNII:B66F4574UG)	ANGELICA SINENSIS ROOT	15 [hp_X]  in 1 mL
AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q)	AMERICAN GINSENG	15 [hp_X]  in 1 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	15 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	15 [hp_X]  in 1 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	15 [hp_X]  in 1 mL
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU)	BAPTISIA TINCTORIA ROOT	15 [hp_X]  in 1 mL
BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN)	BARIUM CARBONATE	15 [hp_X]  in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	15 [hp_X]  in 1 mL
LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT)	LYTTA VESICATORIA	15 [hp_X]  in 1 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	15 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	15 [hp_X]  in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	15 [hp_X]  in 1 mL
PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN)	PHOSPHORIC ACID	15 [hp_X]  in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	15 [hp_X]  in 1 mL
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S)	RUTA GRAVEOLENS FLOWERING TOP	15 [hp_X]  in 1 mL
SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS)	SAW PALMETTO	15 [hp_X]  in 1 mL
SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B)	SELENIUM	15 [hp_X]  in 1 mL
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)	ZINC	15 [hp_X]  in 1 mL
GINKGO (UNII: 19FUJ2C58T) (GINKGO - UNII:19FUJ2C58T)	GINKGO	8 [hp_X]  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55714-4624-1	29.57 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	06/01/2011	01/31/2019
2	NDC: 55714-4624-2	59.14 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	06/01/2011	01/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/01/2011	01/31/2019

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Business Operations
Newton Laboratories, Inc.		788793610	manufacture(55714-4624)

Revised: 1/2019

Document Id: 8fa16dc6-0ef4-2f48-e053-2a95a90a83ed

34391-3

Set id: e2a3801f-5337-ca42-0d72-2707f8e4b828

Version: 6

Effective Time: 20190131