COOL AND HEAT SORE MUSCLE ROLLER EVORA LABS- menthol liquid

Cool and Heat Sore Muscle Roller by

Drug Labeling and Warnings

Cool and Heat Sore Muscle Roller by is a Otc medication manufactured, distributed, or labeled by Evora Worldwide, Inspec Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient                                               Purpose

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

PURPOSE

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COOL AND HEAT SORE MUSCLE ROLLER   EVORA LABS
menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77375-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	16 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77375-008-02	1 in 1 CARTON	12/21/2020
1		74 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/21/2020

Labeler - Evora Worldwide (081336028)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC		081030372	manufacture(77375-008)