THERACARE ROLL-ON MENTHOL 4% PAIN RELIEF- menthol gel

TheraCare Roll-on Menthol 4% Pain Relief by

Drug Labeling and Warnings

TheraCare Roll-on Menthol 4% Pain Relief by is a Otc medication manufactured, distributed, or labeled by Veridian Healthcare, Nantong Health & Beyond Hygienic Products Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

TheraCare Roll-on Menthol 4% Pain Relief Gel

Active ingredient

Menthol 4%

Purpose

Topical analgesic

Uses

Uses Temporarily relieves minor pain associated with: ■ arthritis ■ simple backache ■ muscle strains ■ sprains ■ bruises

Warnings

For external use only

When using this product

When using this product

■ use only as directed. Read and follow all directions and warnings on this carton

■ rare cases of serious burns have been reported with products of this type

■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use
■ 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 the product to heat or direct sunlight
■ avoid applying into skin folds

Stop use and ask a doctor if

• condition worsens
• redness is present
• irritation develops
• symptoms persist for more than 7 days or clear up and occur again within a few days
• you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

Flammable■ Keep away from fire or flame

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 (1-800-222-1222) right away.

Directions

Adults and children over 12 years:■ apply a thin layer to affected area
■ massage into painful area until thoroughly absorbed into skin
■ repeat as 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

Inactive ingredients

Inactive ingredients aloe barbadensis leaf juice, aminomethyl propanol, arctium lappa extract, arnica montana flower extract, boswellia serrata extract, calendula officinalis flower extract, camellia sinensis leaf extract, camphor, carbomer, FD&C blue no.1, FD&C yellow no.5, glycerin, ilex paraguariensis leaf extract, isopropyl alcohol, isopropyl myristate, melissa officinalis leaf extract, methyl methacrylate crosspolymer, tocopheryl acetate, water

Questions or comments

Call 1-866-326-1313

Principal Display Panel

INGREDIENTS AND APPEARANCE

THERACARE ROLL-ON MENTHOL 4% PAIN RELIEF 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71101-090
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER 940 (UNII: 4Q93RCW27E)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
AMINOMETHYL PROPANOL (UNII: LU49E6626Q)
ALCOHOL (UNII: 3K9958V90M)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
WATER (UNII: 059QF0KO0R)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
ARCTIUM LAPPA WHOLE (UNII: 73070DU1LA)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71101-090-01	1 in 1 CARTON	09/01/2025
1		73 mL in 1 BOTTLE, WITH APPLICATOR; 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	09/01/2025

Labeler - Veridian Healthcare (830437997)

Establishment
Name	Address	ID/FEI	Business Operations
Nantong Health & Beyond Hygienic Products Inc		421280161	manufacture(71101-090)