FDA.reportPublic FDA data

X Ray Pain Relieving

Manufacturer
Genomma Lab | Product Quest Mfg.
Effective date
2018-04-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:55:10

Label at a glance#

ProductX Ray Pain Relieving
Active ingredientMenthol, Methyl Salicylate
Label structure7 sections

Indications and uses

Temporary relief of minor aches and pains of muscles and joints associated with simple backache bruises arthritis sprains strains

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 : Consult a doctor.

Label contents#

Full prescribing information#

Active ingredients                              Purpose

OTC - ACTIVE INGREDIENT SECTION

Menthol-10% .................................... Topical Analgesic
Methyl Salicylate -15% .....................Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporary relief of minor aches and pains of muscles

and joints associated with

  • simple backache
  • bruises
  • arthritis
  • sprains
  • strains

Warnings

WARNINGS SECTION

For external use only


Do not use

  • on wounds or damaged, broken or irritated skin
  • with heating pad

When using this product

  • use only as directed
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

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

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: Consult a doctor.

INACTIVE INGREDIENT SECTION

Aminomethyl Propanol,Carbomer,Cetyl Alcohol,Glycerin,Glyceryl Stearate,Isopropyl Palmitate,Potassium Cetyl Phosphate,Stearic Acid,Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311498menthol 10 % / methyl salicylate 15 % Topical CreamPSN2
311498menthol 100 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCD2
311498menthol 10 % / methyl salicylate 15 % Topical CreamSY2
311498menthol 10 GM / methyl salicylate 15 GM per 100 GM Topical CreamSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50066-501-032020-01-31C16284748780-19d75b9cf-ce03-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-501-03X Ray Pain Relieving89 mL in 1 TUBECREAM892
50066-501-03X Ray Pain Relieving1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-501X RAY PAIN RELIEVING (MENTHOL - 10.00% METHYL SALICYLATE - 15.00%) CREAM [GENOMMA LAB]2Legacy NDC, 2 package rows20180405_895f3cc0-719b-4553-a49e-021ceee65a7d.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50066-50150066-501-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
MentholL7T10EIP3AACTIB
Methyl SalicylateLAV5U5022YACTIB
AMINOMETHYLPROPANOLLU49E6626QIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
Cetyl Alcohol936JST6JCNIACT
GlycerinPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
Isopropyl Palmitate8CRQ2TH63MIACT
Potassium Cetyl Phosphate03KCY6P7UTIACT
Stearic Acid4ELV7Z65APIACT
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
07a9b5fe-40b1-4805-8138-5250b531e885895f3cc0-719b-4553-a49e-021ceee65a7d2018-04-05WarningsExact identifier
spl id: 07a9b5fe-40b1-4805-8138-5250b531e885
spl set id: 895f3cc0-719b-4553-a49e-021ceee65a7d

Reported adverse events (FAERS/openFDA)#

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