Prime + 1101L

Drug Labeling and Warnings

Drug Details [pdf]

PRIME PLUS- 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 drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

Prime + 1101L

 INDICATIONS AND USAGE SECTION

Prime+    Formulated for symptoms associated with aging such as impaired memory, loss of vitality, general weakness and dry, wrinkled skin. 

DOSAGE AND 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. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC ACTIVE INGREDIENT SECTION

Agnus 10x, Allium sativum 10x, Ambra10x, Angelica sinensis radix 10x, Aralia quinquefolia 10x, Arnica 10x, Arsenicum alb. 10x, Avena 10x, Baptisia 10x, Baryta carb. 10x, Bryonia 10x, Cantharis 10x, Lachesis 10x, Lycopodium 10x, Nux vom.10x, Phosphoricum ac. 10x, Pulsatilla 10x, Ruta 10x, Sabal 10x, Selenium 10x, Zinc. met. 10x, Ginkgo 3x, Ruta 3x.

OTC PURPOSE SECTION

Formulated for symptoms associated with aging such as impaired memory, loss of vitality, general weakness and dry, wrinkled skin.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: 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

OTC - 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. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PRIME PLUS 
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 OTC DRUG	Item Code (Source)	NDC: 55714-1101
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHASTE TREE (UNII: 433OSF3U8A) (CHASTE TREE - UNII:433OSF3U8A)	CHASTE TREE	10 [hp_X]  in 1 mL
GARLIC (UNII: V1V998DC17) (GARLIC - UNII:V1V998DC17)	GARLIC	10 [hp_X]  in 1 mL
AMBERGRIS (UNII: XTC0D02P6C) (AMBERGRIS - UNII:XTC0D02P6C)	AMBERGRIS	10 [hp_X]  in 1 mL
ANGELICA SINENSIS ROOT (UNII: B66F4574UG) (ANGELICA SINENSIS ROOT - UNII:B66F4574UG)	ANGELICA SINENSIS ROOT	10 [hp_X]  in 1 mL
AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q)	AMERICAN GINSENG	10 [hp_X]  in 1 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	10 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	10 [hp_X]  in 1 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	10 [hp_X]  in 1 mL
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU)	BAPTISIA TINCTORIA ROOT	10 [hp_X]  in 1 mL
BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN)	BARIUM CARBONATE	10 [hp_X]  in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	10 [hp_X]  in 1 mL
LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT)	LYTTA VESICATORIA	10 [hp_X]  in 1 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	10 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	10 [hp_X]  in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	10 [hp_X]  in 1 mL
PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN)	PHOSPHORIC ACID	10 [hp_X]  in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	10 [hp_X]  in 1 mL
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S)	RUTA GRAVEOLENS FLOWERING TOP	10 [hp_X]  in 1 mL
SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS)	SAW PALMETTO	10 [hp_X]  in 1 mL
SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B)	SELENIUM	10 [hp_X]  in 1 mL
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)	ZINC	10 [hp_X]  in 1 mL
GINKGO (UNII: 19FUJ2C58T) (GINKGO - UNII:19FUJ2C58T)	GINKGO	3 [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: 55714-1101-1	29.57 mL in 1 BOTTLE, GLASS
2	NDC: 55714-1101-2	59.14 mL in 1 BOTTLE, GLASS
3	NDC: 55714-1101-0	14.78 mL in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/01/2011	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(55714-1101)

Revised: 8/2019

Document Id: 8f9eba2f-59cc-7229-e053-2995a90aec50

34390-5

Set id: 74688ebd-955f-eaf1-dea1-1602154f4784

Version: 4

Effective Time: 20190808