FDA.reportPublic FDA data

Green Compass Reduce Roll-On Pain Relief

Manufacturer
Royal Labs Natural Cosmetics, Inc.
Effective date
2021-01-16
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
legacy-cache
Hydrated at
2026-08-01 22:56:11

Label at a glance#

ProductGreen Compass Reduce Roll-On Pain Relief
Active ingredientMENTHOL
Label structure10 sections

Indications and uses

For temporary relief of minor aches and pains of muscles and joints.

Dosage and administration

Adults and children 12 years of age and older: apply to affected areas no more than 3 to 4 times daily Children under 12 years of age: ask a doctor

Label contents#

Full prescribing information#

PURPOSE

OTC - PURPOSE SECTION

Topical Analgesic

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

WARNINGS

WARNINGS SECTION

For external use only.

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens
symptoms last more than 7 days
condition clears up and occurs again within a few days

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Do not use

OTC - DO NOT USE SECTION

on wounds or damaged skin
with a heating pad

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older: apply to affected areas no more than 3 to 4 times daily

Children under 12 years of age: ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Full Spectrum Hemp Flower Extract, Hydroxyethylcellulose, Ethyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Heptyl Glucoside, Organic Aloe Barbadensis Leaf Juice, Tocopherol, Arnica Montana (Arnica) Flower Extract, Cinnamomom Camphora (Camphor) Bark Oil, Lavandula Angustifolia (Lavender) Flower Oil, Xanthan Gum, Glyceryl Caprylate, Caprylhydroxamic Acid.

Uses

INDICATIONS & USAGE SECTION

For temporary relief of minor aches and pains of muscles and joints.

REDUCE Roll-On Pain Relief

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image (1).jpgimage (1).jpg

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
69580-78469580-784-54

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUNFLOWER OIL3W1JG795YIIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
ALCOHOL3K9958V90MIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
EUCALYPTUS OIL2R04ONI662IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
CAMPHOR OIL75IZZ8Y727IACT
CANNABIS SATIVA FLOWERING TOP8X454SZ22DIACT
ALOE VERA LEAFZY81Z83H0XIACT
LAVENDER OILZBP1YXW0H8IACT
HEPTYL GLUCOSIDEBU2OC48XBRIACT
MENTHOLL7T10EIP3AACTIB
XANTHAN GUMTTV12P4NEEIACT
ARNICA MONTANAO80TY208ZWIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT

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
b90455b7-751e-1335-e053-2a95a90a44a7b830973c-4616-4275-e053-2a95a90aad4e2021-01-16WarningsExact identifier
spl id: b90455b7-751e-1335-e053-2a95a90a44a7
spl set id: b830973c-4616-4275-e053-2a95a90aad4e

Reported adverse events (FAERS/openFDA)#

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