MYGRIN ROLL-ON- menthol gel 
Sunascen Therapeutics LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

ACTIVE INGREDIENTS

Menthol, USP 3.5%


PURPOSE

External Analgesic (Cooling Pain Relief)


INDICATIONS AND USAGE

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


WARNINGS

For external use only

Flammable

Keep away from excessive heat or open flame

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

Ask a doctor before use if you have,

  • Sensitive skin

Stop use and ask a doctor if,

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

If pregnant or breastfeeding,

ask a health professional before use.

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.


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.


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.


OTHER INFORMATION


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 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
SUNASCEN THERAPEUTICS LLC 210

MYGRIN ROLL-ON 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49467-210
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL35 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ANGELICA ARCHANGELICA ROOT (UNII: DTN01M69SN)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49467-210-031 in 1 CARTON02/05/2018
190 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/05/2018
Labeler - Sunascen Therapeutics LLC (078272834)
Registrant - Sunascen Therapeutics LLC (078272834)
Establishment
NameAddressID/FEIBusiness Operations
Sunascen Therapeutics LLC078272834label(49467-210)

Revised: 1/2023
Document Id: f397d737-a688-c4e3-e053-2a95a90ac146
Set id: d55e92fa-0cbb-4510-bcfc-3e13847abf2d
Version: 14
Effective Time: 20230131
 
Sunascen Therapeutics LLC