Mygrin ® - DailyMed Details

Mygrin ®

SPL v14

SPL

SPL Set ID d55e92fa-0cbb-4510-bcfc-3e13847abf2d

Route

TOPICAL

Published

Effective Date 2019-01-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Menthol (35 mg)

Inactive Ingredients

Angelica Archangelica Root Aloe Vera Leaf Camphor (natural) Carbomer Homopolymer Type C Dmdm Hydantoin Isopropyl Alcohol Methylparaben Asian Ginseng Water Trolamine

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2018-02-05

Description

Menthol, USP 3.5%

Indications and Usage

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

Purpose

External Analgesic (Cooling Pain Relief)

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.

Medication Information

Indications and Usage

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

Purpose

External Analgesic (Cooling Pain Relief)

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.

Description

Menthol, USP 3.5%

Warnings

For external use only

Flammable

Keep away from excessive heat or open flame

Other Information

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

Active Ingredients

Menthol, USP 3.5%

Inactive Ingredients

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?

Sunascen Therapeutics LLC

Call us toll free at 1-833-SUNASCN (786-2726) Mon-Fri 9am-5pm EST.

Email us at [email protected]

More information is available on our website at www.sunascen.com

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

When Using This Product,

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

If Pregnant Or Breastfeeding,

ask a health professional before use.

Keep Out of Reach of Children

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.

Stop Use and Ask A Doctor If,

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

Keep Out of the Reach of Children

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.

Ask A Doctor Before Use If You Have,

Sensitive skin

Dosage and Administration (directions)

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.

Structured Label Content

Purpose (PURPOSE)

External Analgesic (Cooling Pain Relief)

Warnings (WARNINGS)

For external use only

Flammable

Keep away from excessive heat or open flame

Other Information (OTHER INFORMATION)

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

Active Ingredients (ACTIVE INGREDIENTS)

Menthol, USP 3.5%

Inactive Ingredients (INACTIVE INGREDIENTS)

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

Indications and Usage (INDICATIONS AND USAGE)

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

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Sunascen Therapeutics LLC

Call us toll free at 1-833-SUNASCN (786-2726) Mon-Fri 9am-5pm EST.

Email us at [email protected]

More information is available on our website at www.sunascen.com

Principal Display Panel (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

Sunascen Therapeutics LLC

Quality Guaranteed

Please Recycle

When Using This Product, (When using this product,)

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

If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

ask a health professional before use.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

Stop Use and Ask A Doctor If, (Stop use and ask a doctor if,)

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

Keep Out of the Reach of Children (Keep out of the reach of children)

Ask A Doctor Before Use If You Have, (Ask a doctor before use if you have,)

Sensitive skin

Dosage and Administration (directions) (DOSAGE AND ADMINISTRATION (Directions))

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.

Advanced Ingredient Data

[{"name": "ANGELICA ARCHANGELICA ROOT", "unii": "DTN01M69SN", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAMPHOR (NATURAL)", "unii": "N20HL7Q941", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER TYPE C", "unii": "4Q93RCW27E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DMDM HYDANTOIN", "unii": "BYR0546TOW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ASIAN GINSENG", "unii": "CUQ3A77YXI", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "35", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"PURPOSE": "External Analgesic (Cooling Pain Relief)", "WARNINGS": "For external use only", "Flammable": "Keep away from excessive heat or open flame", "OTHER INFORMATION": "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", "ACTIVE INGREDIENTS": "Menthol, USP 3.5%", "INACTIVE INGREDIENTS": "Aloe barbadensis leaf extract, angelica archangelica root extract, camphor, carbomer, DMDM hydantoin, isopropyl alcohol, methylparaben, panax ginseng root extract, purified water, triethanolamine.", "INDICATIONS AND USAGE": "For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, backache, bruises, strains, and sprains.", "QUESTIONS OR COMMENTS?": "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": "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", "When using this product,": "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", "If pregnant or breastfeeding,": "ask a health professional before use.", "KEEP OUT OF REACH OF CHILDREN": "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.", "Stop use and ask a doctor if,": "Conditions worsens Symptoms persist for more than 7 days Condition clears up and reoccurs", "Keep out of the reach of children": "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.", "Ask a doctor before use if you have,": "Sensitive skin", "DOSAGE AND ADMINISTRATION (Directions)": "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:33.299865 · Updated: 2026-03-14T23:01:01.701433