Prime

Manufacturer
Newton Laboratories, Inc.
Effective date
2025-02-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:31:59

Label at a glance#

ProductPrime
Active ingredientPHOSPHORIC ACID, GINKGO, GARLIC, AMBERGRIS, ANGELICA SINENSIS ROOT, AMERICAN GINSENG, ARNICA MONTANA, ARSENIC TRIOXIDE, AVENA SATIVA FLOWERING TOP, BAPTISIA TINCTORIA ROOT, BARIUM CARBONATE, BRYONIA ALBA ROOT, LYTTA VESICATORIA, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, ANEMONE PULSATILLA, RUTA GRAVEOLENS FLOWERING TOP, SAW PALMETTO, SELENIUM, ZINC, CHASTE TREE FRUIT
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions: Adults, take 6 drops by mouth one to four times daily or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Ginkgo biloba 6x, Ruta graveolens 6x, Agnus castus 15x, Allium sativum 15x, Ambra grisea 15x, Angelica sinensis radix 15x, Aralia quinquefolia 15x, Arnica montana 15x, Arsenicum album 15x, Avena sativa 15x, Baptisia tinctoria 15x, Baryta carbonica 15x, Bryonia 15x, Cantharis 15x, Lachesis mutus 15x, Lycopodium clavatum 15x, Nux vomica 15x, Phosphoricum acidum 15x, Pulsatilla 15x, Ruta graveolens 15x, Sabal serrulata 15x, Selenium metallicum 15x, Zincum metallicum 15x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with aging such as impared 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 alcohol 20%.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2552-1Prime30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2552PRIME (GINKGO BILOBA, RUTA GRAVEOLENS, AGNUS CASTUS, ALLIUM SATIVUM, AMBRA GRISEA, ANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARNICA MONTANA, ARSENICUM ALBUM, AVENA SATIVA, BAPTISIA TINCTORIA, BARYTA CARBONICA, BRYONIA, CANTHARIS, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PULSATILLA, RUTA GRAVEOLENS, SABAL SERRULATA, SELENIUM METALLICUM, ZINCUM METALLICUM.) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20250213_9b40f630-0b91-9816-e053-2a95a90a16ec.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-255255714-2552-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PrimeGINKGO BILOBA, RUTA GRAVEOLENS, AGNUS CASTUS, ALLIUM SATIVUM, AMBRA GRISEA, ANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARNICA MONTANA, ARSENICUM ALBUM, AVENA SATIVA, BAPTISIA TINCTORIA, BARYTA CARBONICA, BRYONIA, CANTHARIS, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PULSATILLA, RUTA GRAVEOLENS, SABAL SERRULATA, SELENIUM METALLICUM, ZINCUM METALLICUM.Newton Laboratories, Inc.9b40f630-0b91-9816-e053-2a95a90a16ec2025-02-10WarningsExact identifier
ndc (package): 55714-2552-1
ndc (product): 55714-2552
ndc11 (package): 55714255201
spl id: 2dd1e42d-6f1d-a6fb-e063-6294a90ad8d7
spl set id: 9b40f630-0b91-9816-e053-2a95a90a16ec

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.