FDA.reportPublic FDA data

Graston REVIVE Post Treatment

Manufacturer
Graston Technique, LLC | Specialty Formulations and Manufacturing LLC | Dynamic Blending Specialists, Inc. | United Laboratories Manufacturing, LLC
Effective date
2022-12-05
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:18:47

Label at a glance#

ProductGraston REVIVE Post Treatment
Active ingredientARNICA MONTANA
Label structure7 sections

Label contents#

Full prescribing information#

WARNINGS SECTION

Warnings: for external use only, avoid contact with eyes, Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center immediately, if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician, Pregnancy-breast feeding warning: if pregnant or breast feeding, ask a health professional before use, do not bandage tightly

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose

2% Arnica Montana 3X HPUS

INDICATIONS & USAGE SECTION

Directions: Use by itself or with DOCTOR HOY'S Natural Pain Relief Gel. For adults and children 2 years and older. "Children under 2 years of age: consult a doctor." For best results, apply generously to affected and surrounding areas. Repeat as needed.

Uses: for the temporary relief of minor aches and pains of muscles and joints due to: , inflammation, arthritis, sprains, strains, bruises

INACTIVE INGREDIENT SECTION

Inactive Ingredients: arnica montana extract, deionized water, hamamelis virginiana (witch hazel extract), isopropyl alcohol, cetyl alcohol, glycerin, tocopheryl acetate (vitamin E), aloe vera, argan oil, calendula oil, chamomile, hyperium Perforatum Extract, safflower oil, tilia cordata flower extract

OTC - PURPOSE SECTION

Uses: for the temporary relief of minor aches and pains of muscles and joints associated with: Inflammation, arthritis, sprains, strains, bruises, Expedites healing, Reduces swelling, Extends relief time, Absorbs quickly, Odorless

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Warnings: for external use only, avoid contact with eyes, Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center immediately, if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician, Pregnancy-breast feeding warning: if pregnant or breast feeding, ask a health professional before use, do not bandage tightly

DOSAGE & ADMINISTRATION SECTION

Directions: Use by itself or with DOCTOR HOY'S Natural Pain Relief Gel. for adults and children 2 years and older. "Children under 2 years of age: consult a doctor." For best results, apply generously to affected and surrounding areas. Repeat as needed.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GrastonGraston

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73080-100-012024-01-30C16284748780-11030e365-59e9-111a-e063-dadaa90a10e2Graston Revive
73080-100-022024-01-30C16284748780-11030e365-59e9-111a-e063-dadaa90a10e2Graston Revive

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73080-100-01Graston REVIVE Post Treatment119 mL in 1 TUBECREAM1196
73080-100-02Graston REVIVE Post Treatment6 mL in 1 PACKETCREAM66

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73080-100GRASTON REVIVE POST TREATMENT (HPUS ARNICA MONTANA) CREAM [GRASTON TECHNIQUE, LLC]6Legacy NDC, 2 package rows20221206_87b0a713-d4db-4b29-e053-2a95a90a9d09.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73080-10073080-100-02, 73080-100-01
10842-203

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CHAMOMILEFGL3685T2XIACT
HYPERICUM PERFORATUMXK4IUX8MNBIACT
.ALPHA.-TOCOPHEROL, D-N9PR3490H9IACT
PANTHENOLWV9CM0O67ZIACT
SAFFLOWER OIL65UEH262ISIACT
CETEARYL OLIVATE58B69Q84JOIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
WITCH HAZEL101I4J0U34IACT
CETYL ALCOHOL936JST6JCNIACT
JOJOBA OIL724GKU717MIACT
ARGAN OIL4V59G5UW9XIACT
ARNICA MONTANAO80TY208ZWACTIB

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
ef195bfa-4471-e58b-e053-2a95a90a707387b0a713-d4db-4b29-e053-2a95a90a9d092022-12-05WarningsExact identifier
spl id: ef195bfa-4471-e58b-e053-2a95a90a7073
spl set id: 87b0a713-d4db-4b29-e053-2a95a90a9d09

Reported adverse events (FAERS/openFDA)#

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