FDA.reportPublic FDA data

Hot Stuff

Manufacturer
Mueller Sports Medicine
Effective date
2019-04-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:59:23

Label at a glance#

ProductHot Stuff
Active ingredientMENTHOL, METHYL SALICYLATE
Label structure9 sections

Indications and uses

Temporarily relieves pain from sore muscles minor aches sprains strains bruises

Dosage and administration

Adults and children 12 years of age and over: 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 Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Menthol 3%

Methyl Salicylate 15%

Pupose

OTC - PURPOSE SECTION

Purpose

Topical Analgesic

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves pain from

  • sore muscles
  • minor aches
  • sprains
  • strains
  • bruises

WARNINGS SECTION

For external use only

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

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • avoid contact with eyes or mucous membranes
  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use with a heating pad
  • do not use immediately after a shower or bath

Stop use and ask a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if condition worsens

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

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of children

  • if swallowed, get medical help or contact a Poison Control center right away

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and over: apply to affected area not more than 3 to 4 times daily

Children under 12 years of age: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cetyl Alcohol, Cetyl Palmitate, Glyceryl Stearate, Methyl Paraben, Mineral Oil, Polysorbate 80, Propylene Glycol, Propyl Paraben, Water

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-356-9522 or

Email us at sportcare@muellersportsmed.com

OTHER SAFETY INFORMATION

STORE AT NORMAL ROOM TEMPERATURE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2166923menthol 3 % / methyl salicylate 15 % Topical CreamPSN1
2166923menthol 30 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCD1
2166923menthol 3 % / methyl salicylate 15 % Topical CreamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52564-108-012022-01-28C16284748780-1d6a99b39-5029-a426-e053-dadaa90af4c28720c9df-4d54-6256-e053-2a91aa0a5071

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52564-108-01Hot Stuff237 g in 1 BOTTLECREAM2371

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52564-108HOT STUFF (MENTHOL, METHYL SALICYLATE) CREAM [MUELLER SPORTS MEDICINE]1Legacy NDC, 1 package rows20190501_8720c9df-4d54-6256-e053-2a91aa0a5071.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
52564-10852564-108-01

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
MINERAL OILT5L8T28FGPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CETYL ALCOHOL936JST6JCNIACT
CETYL PALMITATE5ZA2S6B08XIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
METHYLPARABENA2I8C7HI9TIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLPARABENZ8IX2SC1OHIACT
MENTHOLL7T10EIP3AACTIB
WATER059QF0KO0RIACT
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
8720b77a-8f44-47f8-e053-2a91aa0a239f8720c9df-4d54-6256-e053-2a91aa0a50712019-04-22WarningsExact identifier
spl id: 8720b77a-8f44-47f8-e053-2a91aa0a239f
spl set id: 8720c9df-4d54-6256-e053-2a91aa0a5071

Reported adverse events (FAERS/openFDA)#

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