FDA.reportPublic FDA data

RockSauce FIERY HOT PAIN RELIEF

Manufacturer
Implus Footcare, LLC
Effective date
2025-04-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:58:48

Label at a glance#

ProductRockSauce FIERY HOT PAIN RELIEF
Active ingredientMENTHOL, CAPSAICIN, METHYL SALICYLATE
Label structure11 sections

Indications and uses

Provides soothing heat to sore muscles and joints.

Dosage and administration

Apply liberally to area of pain and massage until lotion is absorbed into the skin. Repeat 3-4 times daily. Store at 68° to 77 ℉(20° to 25℃).

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 20%

Menthol 10%

Capsaicin0.002%

PURPOSE

OTC - PURPOSE SECTION

Topical Analgesic

USES:

INDICATIONS & USAGE SECTION

Provides soothing heat to sore muscles and joints.

WARNINGS:

WARNINGS SECTION

For external use only. Avoid contact with eyes, mucous membrane or broken skin.

When using this product, do not:

OTC - WHEN USING SECTION

heat, microwave, add to hot water or any container where heating water may cause splattering and result in burns, use in eyes or directly on mucus membrane, take by mouth or place in nostrils, apply to wounds or damaged skin.

OTC - DO NOT USE SECTION

Do not use otherwise than as directed.

OTC - ASK DOCTOR SECTION

Consult a doctor and discontinue use if irritation occurs.

Ask a health professional before use if pregnant or breastfeeding.

Ask a doctor before using if you have sensitive skin.

Keep out of reach of children:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, get medical help or call Poison Control Center right away. Not for children 5 years or younger.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Apply liberally to area of pain and massage until lotion is absorbed into the skin. Repeat 3-4 times daily. Store at 68° to 77 ℉(20° to 25℃).

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Aminomethyl Propanol, Aloe Barbadensis(Aloe Vera)Leaf Juice, Arnica Montana Flower Extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cetearyl Alcohol, Ethylhexylglycerin, Maltodextrin, Phenoxyethanol, Propylene Glycol, Potassium Cetyl Phosphate, Tocopheryl Acetate, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of pouch labelimage of pouch label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1921129capsaicin 0.002 % / menthol 10 % / methyl salicylate 20 % Topical CreamPSN3
1921129capsaicin 0.02 MG/ML / menthol 100 MG/ML / methyl salicylate 200 MG/ML Topical CreamSCD3
1921129capsaicin 0.002 % / menthol 10 % / methyl salicylate 20 % Topical CreamSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81683-025-012025-02-18C16284748780-12cef2736-a6f8-d83d-e063-dadaa90ab31f81683-025
81683-025-012025-01-30C16284748780-12cef2736-a6f8-d83d-e063-dadaa90ab31f81683-025

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81683-025-01RockSauce FIERY HOT PAIN RELIEF2.45 mL in 1 POUCHCREAM2.453

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81683-025ROCKSAUCE FIERY HOT PAIN RELIEF (METHYL SALICYLATE, MENTHOL, CAPSAICIN) CREAM [IMPLUS FOOTCARE, LLC]3Current NDC, Legacy NDC, 1 package rows20250409_cc7cbf4a-8274-e463-e053-2995a90a51e0.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81683-02581683-025-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
ALOE VERA LEAFZY81Z83H0XIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
MALTODEXTRIN7CVR7L4A2DIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CAPSAICINS07O44R1ZMACTIB
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
METHYL SALICYLATELAV5U5022YACTIB
AMINOMETHYLPROPANOLLU49E6626QIACT

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
RockSauce FIERY HOT PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAPSAICINImplus Footcare, LLCcc7cbf4a-8274-e463-e053-2995a90a51e02025-04-07WarningsExact identifier
ndc (package): 81683-025-01
ndc (product): 81683-025
ndc11 (package): 81683002501
spl id: 323956e6-36bd-5542-e063-6294a90acd17
spl set id: cc7cbf4a-8274-e463-e053-2995a90a51e0

Reported adverse events (FAERS/openFDA)#

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