THERA PLUS COOL AND HEAT PAIN RELIEVING GEL MENTHOL- menthol liquid

Thera Plus Cool and Heat Pain Relieving Gel Menthol by

Drug Labeling and Warnings

Thera Plus Cool and Heat Pain Relieving Gel Menthol by is a Otc medication manufactured, distributed, or labeled by Fourstar Group USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• store at 20° - 25°C (68° - 77°F)
• store in a cool dry place away from direct sunlight

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:

INGREDIENTS AND APPEARANCE

THERA PLUS COOL AND HEAT PAIN RELIEVING GEL MENTHOL 
menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80684-097
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	160 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CAPSAICIN (UNII: S07O44R1ZM)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80684-097-00	74 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	02/01/2024

Labeler - Fourstar Group USA, Inc. (140099503)