FDA.reportPublic FDA data

ORTHOGEL Menthol 3.5%

Manufacturer
LiquidCapsule Manufacturing LLC
Effective date
2025-07-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:06:47

Label at a glance#

ProductORTHOGEL Menthol 3.5%
Active ingredientMENTHOL
Label structure12 sections

Indications and uses

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

Dosage and administration

adults and children 12 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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 3.5%

Purpose

OTC - PURPOSE SECTION

Pain Relieving Gel

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains of muscles and joints associated with:

  • simple backache 
  • arthritis 
  • strains
  • bruises 
  • sprains

Warnings

WARNINGS SECTION

For external use only.

Flammable: Keep away from excessive heat or open flame

When using this product:

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 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

OTHER SAFETY INFORMATION

  • store at 20–25ºC (68–77ºF)
  • store in a cool dry place away from direct sunlight

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Boswellia Serrata Extract (as B-NHIBITX™), Camphor, Carbomer, Dimethyl Sulfone (as OptiMSM®), FD&C Yellow #5, FD&C Blue #1, Glucosamine HCl, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Methylparaben, Tetrahydrodiferuloylmethane,
Tocopheryl Acetate (Vitamin E Acetate), Triethanolamine, Water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ortho_4oz_tube_10_25_24ortho_4oz_tube_10_25_24

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
808955menthol 3.5 % Topical GelPSN2
808955menthol 0.035 MG/MG Topical GelSCD2
808955menthol 3.5 % Topical GelSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71726-007-02ORTHOGEL Menthol 3.5%113.4 g in 1 TUBEGEL113.42
71726-007-03ORTHOGEL Menthol 3.5%113.4 g in 1 JARGEL113.42
71726-007-04ORTHOGEL Menthol 3.5%453.6 g in 1 BOTTLEGEL453.62
71726-007-05ORTHOGEL Menthol 3.5%907.2 g in 1 BOTTLEGEL907.22
71726-007-06ORTHOGEL Menthol 3.5%3580 g in 1 JUGGEL35802

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71726-00771726-007-02, 71726-007-03, 71726-007-04, 71726-007-05, 71726-007-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
ALOE VERA LEAFZY81Z83H0XIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GLUCOSAMINE HYDROCHLORIDE750W5330FYIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
ISOPROPYL ALCOHOLND2M416302IACT
TETRAHYDRODIFERULOYLMETHANE00U0645U03IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
Water059QF0KO0RIACT

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
ORTHOGEL Menthol 3.5%MENTHOLLiquidCapsule Manufacturing LLC4fd4b7ac-1971-4abe-8fbb-74ab69e120612025-07-09WarningsExact identifier
ndc (package): 71726-007-03
ndc (package): 71726-007-02
ndc (package): 71726-007-04
ndc (package): 71726-007-06
ndc (package): 71726-007-05
ndc (product): 71726-007
ndc11 (package): 71726000704
ndc11 (package): 71726000703
ndc11 (package): 71726000706
ndc11 (package): 71726000702
ndc11 (package): 71726000705
spl id: cea6fae7-e526-454c-81a2-72dea124b5c2
spl set id: 4fd4b7ac-1971-4abe-8fbb-74ab69e12061

Reported adverse events (FAERS/openFDA)#

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