FDA.reportPublic FDA data

XRay ® Pain Relief Cream

Manufacturer
Genomma Lab USA
Effective date
2023-12-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:05:53

Label at a glance#

ProductXRay Pain Relief
Active ingredientMENTHOL, (+)-, CAMPHOR, (-)-, METHYL SALICYLATE
Label structure10 sections

Indications and uses

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

Dosage and administration

use only as directed 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

Storage and handling

store at room temperature 20-25°C (68-77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Camphor 4%Topical analgesic
Menthol 10%Topical analgesic
Methyl salicylate 30%Topical analgesic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Allergy alert

SPL UNCLASSIFIED SECTION

If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Do not use

OTC - DO NOT USE SECTION

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

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

  • do not use otherwise than as directed
  • avoid contact with eyes, mucous membranes or rashes
  • do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • redness is present or irritation or rash develops
  • condition worsens or symptoms persist for more than 7 days
  • symptoms 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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • use only as directed
  • 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

STORAGE AND HANDLING SECTION

store at room temperature 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

ethylparaben, glyceryl monostearate, polysorbate 80, purified water, sorbitan monooleate, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1 877 994 3666

Monday to Friday 8:00 am – 6:00 pm CST

SPL UNCLASSIFIED SECTION

Distributed by:
Genomma Lab USA, Inc.,
Houston, TX 77098

PRINCIPAL DISPLAY PANEL - 56.7 G Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

X RAY®
DOL

ULTRA STRENGTH

Pain Relief Cream

FOR DAILY TREATMENT OF
ARTHRITIS AND JOINT PAIN*

DEEP PENETRATING

FAST ACTING
RELIEF

Topical Analgesic

*See Drug Facts for more information

Camphor 4%
Menthol 10%
Methyl salicylate 30%

NET WT.
2 OZ (56.7 G)

Principal Display Panel - 56.7 G Tube Carton
Principal Display Panel - 56.7 G Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283083camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical CreamPSN1
283083camphor 40 MG/ML / menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCD1
283083camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical CreamSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-456-20XRay Pain Relief1 in 1 CARTONCREAM11
50066-456-20XRay Pain Relief56.7 g in 1 TUBECREAM56.71

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-456XRAY PAIN RELIEF (MENTHOL, (PLUS)-, CAMPHOR, (-)-, AND METHYL SALICYLATE) CREAM [GENOMMA LAB USA]1Current NDC, 2 package rows20231229_5244ddee-fd9e-4df3-8fb3-b16aa321a316.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
50066-45650066-456-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, (+)-C6B1OE8P3WACTIB
CAMPHOR, (-)-213N3S8275ACTIB
METHYL SALICYLATELAV5U5022YACTIB
glyceryl monostearate230OU9XXE4IACT
Water059QF0KO0RIACT
Polysorbate 806OZP39ZG8HIACT
sorbitan monooleate06XEA2VD56IACT
stearic acid4ELV7Z65APIACT
ethylparaben14255EXE39IACT

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
XRay Pain ReliefMENTHOL, (PLUS)-, CAMPHOR, (-)-, AND METHYL SALICYLATEGenomma Lab USA5244ddee-fd9e-4df3-8fb3-b16aa321a3162023-12-27WarningsExact identifier
ndc (package): 50066-456-20
ndc (product): 50066-456
ndc11 (package): 50066045620
spl id: b420f319-e207-49a6-bcc4-d7f71523416e
spl set id: 5244ddee-fd9e-4df3-8fb3-b16aa321a316

Reported adverse events (FAERS/openFDA)#

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