FDA.reportPublic FDA data

Muscle Pain Relief Gel

Manufacturer
Delon Laboratories (1990) Ltd. | Laboratoires Delon
Effective date
2025-01-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:42:06

Label at a glance#

ProductMuscle Pain Relief Gel
Active ingredientMENTHOL
Label structure7 sections

Indications and uses

for the temporary relief of minor aches and pains of muscles and joints

Dosage and administration

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: consult a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 2.0%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of minor aches and pains of muscles and joints

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylates/C10-30 alkyl acrylate crosspolymer, aminomethyl propanol, denatonium benzoate, ethyl alcohol, FD&C blue no. 1, thymol, water

PURORGANICA PAIN RELIEF Cooling Gel Topical Analgesic 3.17 OZ

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PURORGANICA PAIN RELIEF Cooling Gel Topical Analgesic 3.17 OZPURORGANICA PAIN RELIEF Cooling Gel Topical Analgesic 3.17 OZ

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61734-06061734-060-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
DENATONIUM BENZOATE4YK5Z54AT2IACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
ALCOHOL3K9958V90MIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
MENTHOLL7T10EIP3AACTIB
THYMOL3J50XA376EIACT
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
2d6771ca-bb46-d8c3-e063-6394a90a940821634ef8-6966-da33-e063-6394a90ac91f2025-02-05WarningsExact identifier
spl set id: 21634ef8-6966-da33-e063-6394a90ac91f

Reported adverse events (FAERS/openFDA)#

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