THERACARE PAIN RELIEVING MENTHOL GEL- menthol 2% gel

TheraCare Pain Relieving Menthol Gel by

Drug Labeling and Warnings

TheraCare Pain Relieving Menthol Gel by is a Otc medication manufactured, distributed, or labeled by Veridian Healthcare, Umendra Life Sciences. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Menthol 2%

Purpose

• Topical Analgesic

Uses

Uses Temporary relief from minor aches and pains of sore muscles and joints associated with:

■arthritis ■backache ■strains■sprains

Warnings

For external use only

When using this product, do not

When using this product:

■ do not use with other topical pain relievers

■do not use with a heating pads or other heating devices

■ avoid contact with eyes 

■do not bandage tightly

■ do not apply to wounds or damaged skin

Stop use and ask a doctor if

Stop use and ask a doctor if: the condition worsens, or if symptoms persist for more than 7 days or clear up and occur again withing a few days.

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

Keep out of reach of children. In case of accidental ingestion, get medical help orcontact a Poison Control Center (800-222-1222) right away.

Directions

Directions

• clean affected area before applying product
• Adults and children 2 years of age and older apply to the affected area not more than 3 to 4 times daily
• Children under 2 years of age, ask a doctor before using this product

Other information

• do not freeze
• store at room temperature
• keep container tightly closed when  not in use
• do not use, pour, spill or store near heat or open flame

Inactive ingredients

ammonium hydroxide, carbomer, cupric sulfate, FD&C blue No. 1, Isopropyl alcohol, magnesium sulphate anhydrous, sodium hydroxide, thymol, water

TheraCare Pain Relieving Menthol Gel

INGREDIENTS AND APPEARANCE

THERACARE PAIN RELIEVING MENTHOL GEL 
menthol 2% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71101-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
AMMONIA (UNII: 5138Q19F1X)
CARBOMER (UNII: 0A5MM307FC)
CUPRIC SULFATE (UNII: LRX7AJ16DT)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)
THYMOL (UNII: 3J50XA376E)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71101-015-01	1 in 1 BOX	10/01/2025
1		226.8 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	10/01/2025

Labeler - Veridian Healthcare (830437997)

Establishment
Name	Address	ID/FEI	Business Operations
Umendra Life Sciences		878533295	manufacture(71101-015)