FDA.reportPublic FDA data

Pain Reliever Cream

Manufacturer
Trifecta Pharmaceuticals USA, LLC.
Effective date
2024-03-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:09:30

Label at a glance#

ProductPain Reliever Cream
Active ingredientMENTHOL, METHYL SALICYLATE
Label structure14 sections

Dosage and administration

Adults and children 12 years of age or older. Apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age. consult a doctor Unless treating hands, wash hands thoroughly with soap and water immediately after use.

Storage and handling

Store at controlled room temperature 20º-25ºC (68º-77ºF) Questions ? Call 1-800-883-0085

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 10%

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 15%

OTC - PURPOSE SECTION

Topical Analgesic

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains

Warnings

WARNINGS SECTION

For external use only

Do not use:

  • On wounds or damaged, broken, (open) or irritated skin
  • With a heating pad

Stop Use and ask a doctor

OTC - STOP USE SECTION

  • Conditions worsens or does not improve within 7 days
  • Symptoms clear up and occur again within a few days
  • Excessive skin irritation develops

A temporary burning sensation may occur upon application, but generally disappears in a few days

Ask a doctor before use

OTC - ASK DOCTOR SECTION

If you are pregant or breast feeding.

When using this product

OTC - WHEN USING SECTION

Avoid contact with eyes or mucous membrane.

Do not bandage tightly

Keep out of the reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age or older. Apply to the affected area not more than 3 to 4 times daily.

Children under 12 years of age. consult a doctor

  • Unless treating hands, wash hands thoroughly with soap and water immediately after use.

Other Information

STORAGE AND HANDLING SECTION

  • Store at controlled room temperature 20º-25ºC (68º-77ºF)

Questions ?Call 1-800-883-0085

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Carbomer 940, Cetyl alcohol, Glycerol, Glyceryl monostearate, Methylparaben, Polysorbate 80, Propylparaben, Purified Water, Stearic acid, Trolamine

Distributed By

SPL UNCLASSIFIED SECTION

Proudly Distributed By

Associated Wholesale Grocers, Inc.

Kansas City, Kansas

66106

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Best Choice Muscle Rub Cream 050323 CDERBest Choice Muscle Rub Cream 050323 CDER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311498menthol 10 % / methyl salicylate 15 % Topical CreamPSN1
311498menthol 100 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCD1
311498menthol 10 % / methyl salicylate 15 % Topical CreamSY1
311498menthol 10 GM / methyl salicylate 15 GM per 100 GM Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-151-01Pain Reliever Cream114 g in 1 TUBECREAM1141
69396-151-01Pain Reliever Cream1 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-151PAIN RELIEVER CREAM (MENTHOL 10%, METHYL SALICYLATE 15%) CREAM [TRIFECTA PHARMACEUTICALS USA, LLC.]1Current NDC, 2 package rows20240308_130665d6-3de8-cb91-e063-6294a90a2083.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69396-15169396-151-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYSORBATE 806OZP39ZG8HIACT
TROLAMINE9O3K93S3TKIACT
PROPYLPARABENZ8IX2SC1OHIACT
CARBOMER 9404Q93RCW27EIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
METHYLPARABENA2I8C7HI9TIACT
WATER059QF0KO0RIACT
STEARIC ACID4ELV7Z65APIACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB

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 Reliever CreamMENTHOL 10%, METHYL SALICYLATE 15%Trifecta Pharmaceuticals USA, LLC.130665d6-3de8-cb91-e063-6294a90a20832024-03-06WarningsExact identifier
ndc (package): 69396-151-01
ndc (product): 69396-151
ndc11 (package): 69396015101
spl id: 13066b41-67db-9fea-e063-6394a90a9b5c
spl set id: 130665d6-3de8-cb91-e063-6294a90a2083

Reported adverse events (FAERS/openFDA)#

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