meijer ® ROLL-ON Cold Therapy Pain Relieving Gel Topical analgesic

Manufacturer
Meijer Distribution, Inc | Garcoa, Inc. | SV Labs Toronto Corporation
Effective date
2024-02-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:17:52

Label at a glance#

Productmeijer ROLL-ON Cold Therapy Pain Relieving Topical analgesic
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure11 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Dosage and administration

Adults and children 6 years of age and older: Apply to affected area not more than 3-4 times daily. Massage not necessary Children under 6 years of age: Do Not Use.

Storage and handling

store in a cool dry place with lid closed tightly.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Warnings

WARNINGS SECTION

For external use only

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have sensitive skin.

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with the eyes
  • Do not apply to wounds or damaged skin
  • Do not use with other ointments, creams, sprays or liniments
  • Do not apply to irritated skin or if excessive irritation develops
  • Do not bandage tightly
  • Wash hands after use with cool water
  • Do not use with heating pads or heating devices.

Stop use and consult a doctor if

OTC - STOP USE SECTION

  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Flammable

  • keep away from excessive heat or open flame.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 6 years of age and older: Apply to affected area not more than 3-4 times daily. Massage not necessary
  • Children under 6 years of age: Do Not Use.

Other information

STORAGE AND HANDLING SECTION

store in a cool dry place with lid closed tightly.

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, arnica montana flower extract, blue 1, boswellia serrata resin extract, calendula officinalis flower extract, camellia sinensis leaf extract, camphor, carbomer, glycerin, isopropyl alcohol, isopropyl myristate, silica, sodium hydroxide, tocopheryl acetate, water, yellow 5.

Questions or comments?

OTC - QUESTIONS SECTION

1-866-567-8600

SPL UNCLASSIFIED SECTION

DIST. BY MEIJER
DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544

PRINCIPAL DISPLAY PANEL - 74 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

meijer®

ROLL-ON
Cold Therapy
Pain Relieving
Gel

COMPARE TO
BIOFREEZE®
ROLL-ON PAIN RELIEF
ACTIVE INGREDIENT*

MENTHOL 4% |
TOPICAL ANALGESIC

For arthritis, back pain, sore
muscles & joints

Hands-free roll-on applicator

Paraben free

2.5 FL OZ (74 mL)

Principal Display Panel - 74 mL Bottle Label
Principal Display Panel - 74 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
415974menthol 4 % Topical GelPSN2
415974menthol 0.04 MG/MG Topical GelSCD2
415974menthol 4 % Topical GelSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79481-0088-1meijer ROLL-ON Cold Therapy Pain RelievingTopical analgesic74 mL in 1 BOTTLE, WITH APPLICATORGEL742

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79481-008879481-0088-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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
meijer ROLL-ON Cold Therapy Pain Relieving Topical analgesicMENTHOL, UNSPECIFIED FORMMeijer Distribution, Inc8bc3956b-b82d-4ed3-8bc3-db0078466bbc2024-02-22WarningsExact identifier
ndc (package): 79481-0088-1
ndc (product): 79481-0088
ndc11 (package): 79481008801
spl id: f5c1ca8b-f929-4e6f-8f39-43acb5d53738
spl set id: 8bc3956b-b82d-4ed3-8bc3-db0078466bbc

Reported adverse events (FAERS/openFDA)#

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