FDA.reportPublic FDA data

Medterra Pain Relief Menthol Roll-On

Manufacturer
Respect Manufacturing Corporation
Effective date
2025-06-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:03:41

Label at a glance#

ProductMedterra Pain Relief Menthol Roll-On
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure14 sections

Indications and uses

Temporary relief of minor aches and pains of sore muscles & joints associated with: Arthritis·Backache·Strains·Sprains·

Dosage and administration

Apply cream to affected areas daily as needed. Consult with a physician for optimal usage.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Menthol 4%

Warnings

WARNINGS SECTION

For external use only.

Purpose

OTC - PURPOSE SECTION

Cooling Pain Reliever

Uses

INDICATIONS & USAGE SECTION

Temporary relief of minor aches and pains of sore muscles & joints associated with: Arthritis·Backache·Strains·Sprains·

Flammable

WARNINGS SECTION

Keep away from excessive heat or open flame.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

Sensitive Skin

When using this product:

OTC - WHEN USING SECTION

Avoid contact with the eyes or mucous
membranes • Do not apply to wounds or damaged skin • Do not use
with other ointments, creams, sprays orliniments •Do not apply
to irritated skin orif excessive irritation develops • Do not bandage
• Wash hands after use with cool water • Do not use with heating
pad or device • Store in a cool dry place.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

Condition worsens, or if symptoms
persist for more than 7 days, or clear up and recur.

If pregnant or breastfeeding:

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

Keep out of reach of children:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If accidentally ingested, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply cream to affected areas daily as needed. Consult
with a physician for optimal usage.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alcohol Denatured, Arnica Montana Flower
Oil, Hemp Extract, Lavandula Angustifolia (Lavender) Oil, Laureth-7,
Polyacrylamide, Water(Aqua).

OTC - QUESTIONS SECTION

Questions or Comments?

(800) 971-1288 | supportmedterracbd.com

medterracbd.com | @medterracbd

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83696-601-60Medterra Pain Relief Menthol Roll-On59.1 g in 1 BOTTLE, WITH APPLICATORCREAM59.13

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83696-60183696-601-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
EUCALYPTUS OIL2R04ONI662IACT
WATER059QF0KO0RIACT
PEPPERMINT OILAV092KU4JHIACT
CAMPHOR OIL75IZZ8Y727IACT
LAURETH-7Z95S6G8201IACT
C13-14 ISOPARAFFINE4F12ROE70IACT
ALCOHOL3K9958V90MIACT
POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE)RHA9LWJ494IACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
HEMPTD1MUT01Q7IACT
LAVENDER OILZBP1YXW0H8IACT

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
Medterra Pain Relief Menthol Roll-OnMENTHOLRespect Manufacturing Corporation05a6067a-287a-52d4-e063-6394a90a2c4e2025-06-23WarningsExact identifier
ndc (package): 83696-601-60
ndc (product): 83696-601
ndc11 (package): 83696060160
spl id: 384365e6-a1e2-64d6-e063-6394a90a3375
spl set id: 05a6067a-287a-52d4-e063-6394a90a2c4e

Reported adverse events (FAERS/openFDA)#

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