THERA PLUS COOL AND HEAT PAIN RELIEVING GEL MENTHOL- menthol liquid 
Fourstar Group USA, Inc.

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Thera Plus Cool & Heat Pain Relieving Gel Menthol

Drug Facts

Active ingredient

Menthol 16%

Purpose

Topical analgesic

Uses

For the temporarily relief of minor aches and pains of muscles and joints associated with: • simple backache • arthritis • strains • bruises • sprains

Warnings

For external use only.

Test on a small patch of skin before applying generously.

Flammable •keep away from fire or flame

When using this product

• use only as directed • avoid contact with the eyes and mucous membranes • do not apply to wounds or damaged skin • do not
bandage tightly • do not use with heating pads or other heating devices • if redness is present, discontinue use and consult a doctor • if skin irritation occurs, discontinue use • a transient burning sensation may occur upon application but generally disappears in several days

Stop use and ask a doctor if

condition worsens, or if 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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 12 years of age and older: • apply generously to affected area • massage into painful area until thoroughly absorbed into skin • repeat if 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 

Other information

Inactive ingredients

acrylates/c10-30 alkyl acrylate crosspolymer, capsaicin, glycerin, isopropyl myristate, propylene glycol, sd alcohol, triethanoamine, water

Questions or comments?

1-800-639-3803 Weekdays 9 AM to 4 PM EST

Package Labeling:

Outer PackageInner Package

THERA PLUS COOL AND HEAT PAIN RELIEVING GEL MENTHOL 
menthol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80684-097
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL160 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CAPSAICIN (UNII: S07O44R1ZM)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80684-097-0074 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01702/01/2024
Labeler - Fourstar Group USA, Inc. (140099503)

Revised: 11/2023
Document Id: 0b61ea71-e589-bff5-e063-6394a90a2e50
Set id: 0a225714-ccb1-4676-e063-6294a90aeeb2
Version: 2
Effective Time: 20231130
 
Fourstar Group USA, Inc.