FDA.reportPublic FDA data

RockSauce ICY COLD 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 ICY COLD PAIN RELIEF
Active ingredientMENTHOL
Label structure11 sections

Indications and uses

Provides soothing cold 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

Menthol6%

PURPOSE

OTC - PURPOSE SECTION

Topical Analgesic

USES:

INDICATIONS & USAGE SECTION

Provides soothing cold 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

Aloe Barbadensis(Aloe Vera) Leaf Juice, Arctium Lappa(Burdock)Root Extract, Arnica Montana Flower Extract, Carbomer, Chamomilla Recutita (Matricaria) Flower Water, Camellia Sinensis(Green Tea) Leaf Extract, Cinnamomum Camphora Bark Oil, Ethyl Alcohol, Glycerin, Isopropyl Myristate, Ilex Paraguariensis Leaf Extract, Maltodextrin, Triethanolamine, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of bottle labelimage of bottle label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81683-003-012025-02-18C16284748780-12cef2736-6f02-d83d-e063-dadaa90ab31f81683-003
81683-003-012025-01-30C16284748780-12cef2736-6f02-d83d-e063-dadaa90ab31f81683-003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81683-003-01RockSauce ICY COLD PAIN RELIEF88.5 mL in 1 BOTTLEGEL88.53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81683-003ROCKSAUCE ICY COLD PAIN RELIEF (MENTHOL) GEL [IMPLUS FOOTCARE, LLC]3Current NDC, Legacy NDC, 1 package rows20250409_bd4fdff1-9174-31c2-e053-2a95a90a749f.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81683-00381683-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
ARCTIUM LAPPA ROOT597E9BI3Z3IACT
CHAMOMILE FLOWER OIL60F80Z61A9IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CARBOMER 9404Q93RCW27EIACT
ALOE VERA LEAFZY81Z83H0XIACT
CAMPHOR OIL75IZZ8Y727IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
MALTODEXTRIN7CVR7L4A2DIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
ALCOHOL3K9958V90MIACT

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 ICY COLD PAIN RELIEFMENTHOLImplus Footcare, LLCbd4fdff1-9174-31c2-e053-2a95a90a749f2025-04-07WarningsExact identifier
ndc (package): 81683-003-01
ndc (product): 81683-003
ndc11 (package): 81683000301
spl id: 3239950d-8958-aaaa-e063-6394a90a8fa2
spl set id: bd4fdff1-9174-31c2-e053-2a95a90a749f

Reported adverse events (FAERS/openFDA)#

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