GREEN REMEDY COOLING ROLL ON

Manufacturer
EXCLAVE HOLDINGS INC. | JOHN SALSMAN | A.I.G. Technologies Inc.
Effective date
2021-02-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:38:35

Label at a glance#

ProductGREEN REMEDY COOLING ROLL ON
Active ingredientMETHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM
Label structure8 sections

Label contents#

Full prescribing information#

INACTIVE INGREDIENT SECTION

Water

SD Alcohol 40-B

Spearmint Oil

Glycerin

Full Spectrum Hemp Extract

Aloe Barbadensis Leaf Extract

Holly Extract

Arnica Extract

Bamboo Extract

Pea Extract

Glucosamine HCI

Camphor

Eucalyptus Oil

Peppermint Oil

Dimethyl Sulfoxide

Silica Propylene Glycol

Triethanolamine

Carbomer

INDICATIONS & USAGE SECTION

Temporary relief of minor aches and pains of muscle and joints associated with simple backaches, arthritis, strains, sprains, and bruises.

Shake well before use. Apply liberally to affected area. No need to rub in. Repeat if necessary, no more than 4 times daily. Rinse with soap and water to remove. Wash hands with soap and water after use. For children under 12 years of age, consult a physician.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Intended for adult use only. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

OTC - PURPOSE SECTION

Penetrating cooling relief. Temporary relief of minor aches and pains of muscle and joints associated with simple backaches, arthritis, strains, sprains, and bruises.

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate

Menthol

DOSAGE & ADMINISTRATION SECTION

Apply liberally to affected area. No need to rub in. Repeat as necessary, no more than 4 times daily.

WARNINGS SECTION

For external use only. Keep out of eyes and mucous membranes. Do not apply to wounds or damaged skin. Do not bandage. Do not use with heating pad. 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

89mg NDC: 78461-0002-1

Cooling Roll OnCooling Roll On

89mg NDC: 78461-0002-1

Cooling Roll OnCooling Roll On

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78461-0002-12022-07-29C16284748780-1e4f33bdf-a149-d8a0-e053-dadaa90a6e4eGreen Remedy 300mg Cooling Roll On

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78461-0002-1GREEN REMEDY COOLING ROLL ON1 g in 1 BOTTLE, WITH APPLICATORGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78461-0002GREEN REMEDY COOLING ROLL ON (COOLING ROLL ON) GEL [EXCLAVE HOLDINGS INC.]1Legacy NDC, 1 package rows20210227_bbf238e7-3c7a-b3bc-e053-2a95a90af020.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78461-000278461-0002-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 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
bbf238e7-3c7b-b3bc-e053-2a95a90af020bbf238e7-3c7a-b3bc-e053-2a95a90af0202021-02-22WarningsExact identifier
spl id: bbf238e7-3c7b-b3bc-e053-2a95a90af020
spl set id: bbf238e7-3c7a-b3bc-e053-2a95a90af020

Reported adverse events (FAERS/openFDA)#

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