COOL AND HEAT SORE MUSCLE ROLLER- menthol gel

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 Acutens, Inspec Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients                               Purpose

Menthol 16%                                       Topical Analgesic

PURPOSE

Uses:

Temporary relief of minor aches pains of muscles and joints associated with arthritis, simple backache, strains, bruises, and sprains

Warnings For external use only

Flammable: Keep away from fire or flame.

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 symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.If accidentally ingested get medical help or contact a Poison Control Center immediately

Direction

Adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily
Children under 2 years old: consult apfysician

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer
Capsaicin
Glycerin
Isopropyl Myristate
Propylene Glycol
SD Alcohol 40 (30.0%)
Triethanolamine
Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COOL AND HEAT SORE MUSCLE ROLLER 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80551-002
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 g

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: 80551-002-02	70.8 g in 1 CONTAINER; Type 0: Not a Combination Product	03/10/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	03/10/2021

Labeler - Acutens (051133165)