COOL AND HEAT SORE MUSCLE ROLLER  EVORA LABS- menthol liquid 
Evora Worldwide

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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Drug Facts

Active ingredient                                               Purpose


Menthol 16% ..................................................... Topical analgesic

Uses

 temporarily relieves minor pain associated with:
• arthritis • simple backache • muscle strains • sprains • bruises• cramps

Warnings


For externa use only.
When using this product • use only as directed • do not
bandage tightly or use with a heating pad • avoid contact with
eyes and mucous membranes • do not apply to wounds or
damaged, broken or irritated skin • a transient burning sensation
may occur upon application but generally disappears in several
days • if severe burning sensation occurs, discontinue use
immediately • do not expose the area treated with product to heat
or direct sunlight

Stop use and ask doctor if • condition worsens • redness is
present • irritation develops • symptoms persist for more than 7
days or clear up and occur again within a few days
Flammable • keep away from fire or flame
If pregnant or breast-feeding, ask a health professional before
use.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions


adults and children over 12 years: • apply generously to
affected area • massage into painful area until thoroughly
absorbed into skin • repeat as necessary, but no more than 3 to 4
times daily • IF MEDICINE COMES IN CONTACT WITH HANDS,
WASH WITH SOAP AND WATER
Children 12 years or younger: ask a doctor

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate
Crosspolymer, Capsaicin, Glycerin, lsopropyl Myristate, Propylene
Glycol, SD Alcohol 40 (30%), Triethanolamine, Water

Questions?

1-888-793-8450

image description

COOL AND HEAT SORE MUSCLE ROLLER   EVORA LABS
menthol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77375-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
CAPSAICIN (UNII: S07O44R1ZM)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALCOHOL (UNII: 3K9958V90M)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77375-008-021 in 1 CARTON12/21/2020
174 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/21/2020
Labeler - Evora Worldwide (081336028)
Establishment
NameAddressID/FEIBusiness Operations
Inspec Solutions LLC081030372manufacture(77375-008)

Revised: 1/2022
Document Id: d58d9fbc-bf35-091d-e053-2995a90acf52
Set id: c6d8c5cf-cd01-4469-96f0-2b4dceb828ae
Version: 3
Effective Time: 20220114
 
Evora Worldwide