PAIN RELIEF Gel-Roll On

Manufacturer
R & Y Group, LLC | Shanghai Chuangshi Medical Technology (Group) Co., Ltd.
Effective date
2023-11-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:58:30

Label at a glance#

ProductPAIN RELIEF Gel-Roll On
Active ingredientMENTHOL
Label structure12 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 : Rub a thin film over affected areas not more than 4 times daily; massage not necessary ■ Children under 12 years of age : Consult Physician

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 4.0% w/w ...... Purpose: Topical Analgesic

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For External Use Only

Flammable: Keep away from excessive heat or open flame

Ask a doctor before use if you have: Sensitive skin

When using this product

OTC - WHEN USING SECTION

■ Avoid contact with eyes or mucous membranes ■ 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 ■ 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 reoccur

If pregnant or breast-feeding

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 swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

■ Adults and children 12 years of age and older:

Rub a thin film over affected areas not more than 4 times daily; massage not necessary

■ Children under 12 years of age: Consult Physician

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alcohol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carbomer, Camphor, FD&C Blue 1, FD&C Yellow 5, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Silica, Triethanolamine, Vitamin E, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle label:

Bottle labelBottle label

---

Bag (1 bottle) label:

Bag labelBag label

---

Bag (3 bottles) label:

2121

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 128X003Y8623Z83016-331-21.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83016-331-01PAIN RELIEF Gel-Roll On74 mL in 1 BOTTLEGEL742
83016-331-11PAIN RELIEF Gel-Roll On1 in 1 BAGGEL12
83016-331-21PAIN RELIEF Gel-Roll On3 in 1 BAGGEL32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83016-331PAIN RELIEF GEL-ROLL ON (MENTHOL) GEL [R & Y GROUP, LLC]23 package rows20231101_088b81e4-76c8-6680-e063-6294a90acb73.zip

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
83016-33183016-331-01, 83016-331-11, 83016-331-21

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
08fe8fdc-425a-f841-e063-6394a90a0908088b81e4-76c8-6680-e063-6294a90acb732023-11-01WarningsExact identifier
spl id: 08fe8fdc-425a-f841-e063-6394a90a0908
spl set id: 088b81e4-76c8-6680-e063-6294a90acb73

Reported adverse events (FAERS/openFDA)#

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