FDA.reportPublic FDA data

RockSauce ICE

Manufacturer
NINGBO SANTE YING MEDICALAND HEALTHDEVELOPMENT CO.,LTD
Effective date
2019-09-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:00:37

Label at a glance#

ProductRockSauce ICE
Active ingredientMENTHOL
Label structure11 sections

Indications and uses

Provides soothing cold to sore muscles

Dosage and administration

Apply liberally to area of pain and massage until lotion is absorbed into the skin. Repeat 3-4 times daily. See important warnings under "When using this product". Not for childern 5 years or younger. Store at 68° to 77°F (20° to 25°C).

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 6.0%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Provides soothing cold to sore muscles

Warnings

WARNINGS SECTION

For external use only.

Avoid contact with eyes, mucous membrane or broken skin.

When using this product:

OTC - WHEN USING SECTION

do not: 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 membane, take by mouth or place in nostrils, apply to wounds or damaged skin.

Do not use otherwise than as directed.

Consult a doctor and discontinue use

OTC - ASK DOCTOR SECTION

if irritation occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, get medical help or call a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally to area of pain and massage until lotion is absorbed into the skin. Repeat 3-4 times daily. See important warnings under "When using this product". Not for childern 5 years or younger. Store at 68° to 77°F (20° to 25°C).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Isopropyl Alcohol, Glycerin, Aloe Barbadensis Leaf Extract, Calendula Officinalis Extract, Arctium Lappa (Burdock) Root Extract, Ilex Paraguariensis Leaf Extract, Arnica MOntana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis (Green Tea) Leaf Extract, Melissa Officinalis (Lemon Balm) Leaf Extract, Camphor, Isopropyl Myristate, Carbomer, Triethanolamine, Silica, Tocopheryl (Vitamin E) Acetate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RockSauce ICE

Net wt 2.5g

Icy cold pain relief cream

Soothies sore muscles and joints

DISTRIBUTED BY:

Rocktape, Inc

questions: please contact 408-912-7625

made in china

rock sauce chill

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label imagelabel image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73344-101-012021-01-29C16284748780-1ba0f9c33-4650-a910-e053-dadaa90a0b85rocksauce ICE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73344-101-01RockSauce ICE2.5 g in 1 JARGEL2.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73344-101ROCKSAUCE ICE (MENTHOL) GEL [NINGBO SANTE YING MEDICALAND HEALTHDEVELOPMENT CO.,LTD]1Legacy NDC, 1 package rows20190929_6d284f09-e5c6-457a-9b75-a25998dd3d8a.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73344-10173344-101-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
GLYCERINPDC6A3C0OXIACT
ARCTIUM LAPPA ROOT OIL55DGS3F5YGIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
MELISSA OFFICINALIS LEAF OILPTP6R7263MIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT

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
9bf85f38-706b-4086-91fb-e8af77795a066d284f09-e5c6-457a-9b75-a25998dd3d8a2019-09-29WarningsExact identifier
spl id: 9bf85f38-706b-4086-91fb-e8af77795a06
spl set id: 6d284f09-e5c6-457a-9b75-a25998dd3d8a

Reported adverse events (FAERS/openFDA)#

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