THERA PLUS COLD THERAPY PAIN RELIEVING MENTHOL- menthol gel

Thera Plus Cold Therapy Pain Relieving Menthol by

Drug Labeling and Warnings

Thera Plus Cold Therapy Pain Relieving 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 4%

Purpose

Pain Relieving Gel

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with:  simple backache  arthritis  strains  bruises  sprains

Warnings

For external use only.

Flammable:Keep away from excessive heat or open flame

When using this product

• use only as directed
• avoid contact with the eyes or on mucous membranes
• do not apply to wounds or damaged skin
• do not apply to irritated skin or if excessive irritation develops
• do not bandage tightly or use with heating pad or device

Stop use and ask a doctor if

• you experience pain, swelling or blistering of the skin
• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
• arthritic pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age

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 2 years of age and older; rub a thin film over affected area not more than 3 to 4 times daily
• children under 2 years of age: consult a physician
• wash hands after use with cool water

Other information

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

Inactive ingredients

aloe barbadensis leaf juice, arctium lappa extract, arnica montana flower extract, blue1, boswellia serrata extract, calendula officinalis flower extract, camellia sinensis leaf extract, camphor, carbomer, glycerin, ilex paraguariensis leaf extract, isopropyl alcohol, isopropyl myristate, melissa officinalis leaf extract, methyl methacrylate crosspolymer, tocopheryl acetate, triethanoamine, yellow 5, water

Questions or comments?

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

Package Labeling:

INGREDIENTS AND APPEARANCE

THERA PLUS COLD THERAPY PAIN RELIEVING MENTHOL 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80684-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80684-101-00	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)