COOL AND HEAT SORE MUSCLE ROLLER- menthol gel 
Acutens

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Acutens - Cool & Heat (80551-002)



Sore Muscle Roller

Active ingredients                               Purpose

Menthol 16%                                       Topical Analgesic

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.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

image description

COOL AND HEAT SORE MUSCLE ROLLER 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80551-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 g  in 100 g
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:80551-002-0270.8 g in 1 CONTAINER; Type 0: Not a Combination Product03/10/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01703/10/2021
Labeler - Acutens (051133165)

Revised: 1/2024
Document Id: 0f004f03-8867-c658-e063-6394a90a403a
Set id: f76069df-1c8f-4e96-bceb-d838c654c6eb
Version: 6
Effective Time: 20240115
 
Acutens