FDA.reportPublic FDA data

MYGRIN ® Roll-On Gel (Menthol 3.5% USP)

Manufacturer
Sunascen Therapeutics LLC
Effective date
2023-01-31
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
full-release
Hydrated at
2026-05-31 23:53:58

Label at a glance#

ProductMYGRIN Roll-On
Active ingredientMENTHOL
Label structure10 sections

Indications and uses

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

Dosage and administration

Adults and Children 2 years of age and older: Apply to the affected areas not more than four times daily. Children under 2 years of age: Consult a Physician. Shake well before each use.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Menthol, USP 3.5%


PURPOSE

OTC - PURPOSE SECTION

External Analgesic (Cooling Pain Relief)


INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

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


WARNINGS

WARNINGS SECTION

For external use only

Flammable

STORAGE AND HANDLING SECTION

Keep away from excessive heat or open flame

When using this product,

OTC - WHEN USING SECTION

  • Avoid contact with eyes or other mucous membranes
  • Do not use with other liniments such as ointments, creams, lotions, or sprays
  • Do not apply to wounds, damaged skin, irritated skin, or if excessive irritation develops
  • Do not bandage, or use with a heating pad, or similar device

Ask a doctor before use if you have,

OTC - ASK DOCTOR SECTION

  • Sensitive skin

Stop use and ask a doctor if,

OTC - STOP USE SECTION

  • Conditions worsens
  • Symptoms persist for more than 7 days
  • Condition clears up and reoccurs

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If ingested, seek medical attention or contact a Poison Control Center immediately at 1-800-222-1222.
Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


DOSAGE AND ADMINISTRATION (Directions)

DOSAGE & ADMINISTRATION SECTION

Adults and Children 2 years of age and older: Apply to the affected areas not more than four times daily.
Children under 2 years of age: Consult a Physician.
Shake well before each use.


KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If ingested, seek medical help right away or contact a Poison Control Center immediately.
Call Poison Control at 1-800-222-1222.
Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


OTHER INFORMATION

SPL UNCLASSIFIED SECTION

  • Apply product directly onto sore areas
  • Massage well for best results
  • Wash hands well, before and after application using cool water
  • Store at room temperature
  • Use before the expiration date

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Aloe barbadensis leaf extract, angelica archangelica root extract, camphor, carbomer, DMDM hydantoin, isopropyl alcohol, methylparaben, panax ginseng root extract, purified water, triethanolamine.


QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Sunascen Therapeutics LLC
Call us toll free at 1-833-SUNASCN (786-2726) Mon-Fri 9am-5pm EST.
Email us at ConsumerCare@Sunascen.com
More information is available on our website at www.sunascen.com


PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sunascen Therapeutics LLC

NDC 49467-210-03


MYGRIN ® Roll-On Gel
SOOTHING MENTHOL - COOLING PAIN RELIEF
Arthritis, Back Pain, Sore Muscles & Joints
Non-Greasy, Dye-Free, and Non-Staining
With Aloe
3 fl oz (90mL)


SHAKE WELL BEFORE EACH USE
FOR EXTERNAL USE ONLY


Does not contain NSAIDs, Ibuprofen, Aspirin, or Salicylate


"Helping you turn the face of pain into a grin" ™


TAMPER EVIDENT: DO NOT USE IF THE SAFETY SEAL ON THE CARTON IS BROKEN OR MISSING

RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION


Distributed by: Sunascen Therapeutics LLC, Rockville MD 20850-6252
© 2018 Sunascen Therapeutics LLC, All rights reserved.
Trademarks are owned by or licensed to Sunascen Therapeutics LLC


Sunascen Therapeutics LLC
Quality Guaranteed
Please Recycle
SUNASCEN THERAPEUTICS LLC 210SUNASCEN THERAPEUTICS LLC 210

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
808955menthol 3.5 % Topical GelPSN14
808955menthol 0.035 MG/MG Topical GelSCD14
808955menthol 3.5 % Topical GelSY14

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49467-210-032024-07-30C16284748780-1f386c64a-1c89-0266-e053-dadaa90a7c1aMYGRIN ® Roll-On Gel (Menthol 3.5% USP)
49467-210-032024-01-30C16284748780-1f386c64a-1c89-0266-e053-dadaa90a7c1aMYGRIN ® Roll-On Gel (Menthol 3.5% USP)
49467-210-032023-02-09C16284748780-1f386c64a-1c89-0266-e053-dadaa90a7c1aMYGRIN ® Roll-On Gel (Menthol 3.5% USP)
49467-210-032023-01-30C16284748780-1f386c64a-1c89-0266-e053-dadaa90a7c1aMYGRIN ® Roll-On Gel (Menthol 3.5% USP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49467-210-03MYGRIN Roll-On90 mL in 1 BOTTLE, WITH APPLICATORGEL9014
49467-210-03MYGRIN Roll-On1 in 1 CARTONGEL114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49467-210MYGRIN ROLL-ON (MENTHOL) GEL [SUNASCEN THERAPEUTICS LLC]14Legacy NDC, 2 package rows20230211_d55e92fa-0cbb-4510-bcfc-3e13847abf2d.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49467-21049467-210-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANGELICA ARCHANGELICA ROOTDTN01M69SNIACT
ALOE VERA LEAFZY81Z83H0XIACT
CAMPHOR (NATURAL)N20HL7Q941IACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
DMDM HYDANTOINBYR0546TOWIACT
ISOPROPYL ALCOHOLND2M416302IACT
METHYLPARABENA2I8C7HI9TIACT
ASIAN GINSENGCUQ3A77YXIIACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
MENTHOLL7T10EIP3AACTIB

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
f397d737-a688-c4e3-e053-2a95a90ac146d55e92fa-0cbb-4510-bcfc-3e13847abf2d2023-01-31WarningsExact identifier
spl id: f397d737-a688-c4e3-e053-2a95a90ac146
spl set id: d55e92fa-0cbb-4510-bcfc-3e13847abf2d

Reported adverse events (FAERS/openFDA)#

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