FDA.reportPublic FDA data

TheraCare Roll-on Menthol 4% Pain Relief Gel

Manufacturer
Veridian Healthcare | Nantong Health & Beyond Hygienic Products Inc
Effective date
2025-09-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:14:31

Label at a glance#

ProductTheraCare Roll-on Menthol 4% Pain Relief
Active ingredientMENTHOL
Label structure9 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

TheraCare Roll-on Menthol 4% Pain Relief Gel

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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 INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Call 1-866-326-1313

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71101-090-01TheraCare Roll-on Menthol 4% Pain Relief73 mL in 1 BOTTLE, WITH APPLICATORGEL731
71101-090-01TheraCare Roll-on Menthol 4% Pain Relief1 in 1 CARTONGEL11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71101-09071101-090-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER 9404Q93RCW27EIACT
CAMPHOR (NATURAL)N20HL7Q941IACT
AMINOMETHYL PROPANOLLU49E6626QIACT
ALCOHOL3K9958V90MIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
WATER059QF0KO0RIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
MELISSA OFFICINALIS LEAF50D2ZE9219IACT
ARCTIUM LAPPA WHOLE73070DU1LAIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMEREG97988M5QIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
MENTHOLL7T10EIP3AACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheraCare Roll-on Menthol 4% Pain ReliefMENTHOLVeridian Healthcarefa121e5f-94b5-4c1d-9c4e-85bb8ede39452025-09-22WarningsExact identifier
ndc (package): 71101-090-01
ndc (product): 71101-090
ndc11 (package): 71101009001
spl id: 3f694987-bd01-d332-e063-6294a90a5b1f
spl set id: fa121e5f-94b5-4c1d-9c4e-85bb8ede3945

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.