FDA.reportPublic FDA data

PAIN-X

Manufacturer
OL PHARMA TECH,LLC | OL PHARMA TECH,LLC (Drs. Pharmacy)
Effective date
2025-01-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:52:13

Label at a glance#

ProductPAIN-X
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure14 sections

Indications and uses

temporarily relieves the minor aches and pains of muscles and joints associated with: simple backaches arthritis strains bruises sprains

Dosage and administration

adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 2.5%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves the minor aches and pains of muscles and joints associated with:

  • simple backaches
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

for external use only

Do not use

OTC - DO NOT USE SECTION

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions

Ask a doctor before use

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have redness over the affected area.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

Keep out of reach of children

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor

Other information

OTHER SAFETY INFORMATION

  • store at 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Vitamin E, Propylene glycol,Polysorbate 80,Water, Isopropyl alcohol,Carbomer interpolymer typ A, edta, Methylparaben, Propylparaben.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pain XPain X

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
282805menthol 2.5 % Topical GelPSN4
282805menthol 0.025 MG/MG Topical GelSCD4
282805menthol 2.5 % Topical GelSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80489-003-01PAIN-X1 in 1 CARTONGEL14
80489-003-01PAIN-X28.3 g in 1 TUBEGEL28.34
80489-003-02PAIN-X1 in 1 CARTONGEL14
80489-003-02PAIN-X49.6 g in 1 TUBEGEL49.64

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80489-003PAIN-X (MENTHOL) GEL [OL PHARMA TECH,LLC]4Current NDC, Legacy NDC, 4 package rows20250112_b22bb19a-14e5-3d32-e053-2a95a90ae520.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80489-00380489-003-01, 80489-003-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
PROPYLPARABENZ8IX2SC1OHIACT
METHYLPARABENA2I8C7HI9TIACT
POLYSORBATE 806OZP39ZG8HIACT
EDETATE DISODIUM7FLD91C86KIACT
ISOPROPYL ALCOHOLND2M416302IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
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
PAIN-XMENTHOLOL PHARMA TECH,LLCb22bb19a-14e5-3d32-e053-2a95a90ae5202025-01-09WarningsExact identifier
ndc (package): 80489-003-02
ndc (package): 80489-003-01
ndc (product): 80489-003
ndc11 (package): 80489000301
ndc11 (package): 80489000302
spl id: 2b51e8c1-1805-573d-e063-6294a90a2f58
spl set id: b22bb19a-14e5-3d32-e053-2a95a90ae520

Reported adverse events (FAERS/openFDA)#

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