ICY COLD PAIN RELIEF CREAM SOOTHES SORE MUSCLES AND JOINTS

Manufacturer
Ningbo Pulisi Daily Chemical Products Co.,Ltd.
Effective date
2017-12-07
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-05-31 22:53:17

Label at a glance#

Productrocksauce ice
Active ingredientMENTHOL
Label structure10 sections

Indications and uses

For temporary relief minor muscular discomfort

Dosage and administration

For the temporary relief of minor muscular discomfort. See important warnings under "When using this product". Not for use on children 5 years or younger. Apply liberally to painful area and massage until lotion is absorbed into the skin. Repeat 3-4 times daily. Store at 68 to 77F (20 to 25 C)

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol     6%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

For temporary relief minor muscular discomfort

Warnings:

WARNINGS SECTION

For external use only.

Avoid contact with eyes, mucous membrane or broken skin

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

if accidentally ingested, getmedical help or contact a Poison Control Center immediately.

Directions:

DOSAGE & ADMINISTRATION SECTION

For the temporary relief of minor muscular discomfort. See important warnings under "When using this product". Not for use on children 5 years or younger. Apply liberally to painful area and massage until lotion is absorbed into the skin. Repeat 3-4 times daily. Store at 68 to 77F (20 to 25 C)

When using this product

OTC - WHEN USING SECTION

do not heat, microwave, and to hot water or any container where heating water may cause splattering and result in burns, use in eyes or directly on mucus membrans, take by mouth or place in nostrill, apply to wounds or damaged skin. Do not use otherwise than as directed

Consult a doctor and discontinus use.

OTC - STOP USE SECTION

if conditions persist for more than 1 week or reocur.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

2-amino-2-methyl-1-propanol, Aloe barbadensis (aloe vera) Leaf Extract, Arnica Montana Extract, Carbomer, Cetearyl Alcohol, Ethylhexylglycerin, Ethylhexyl, Palmitate, Glycerin, Methylisothiazolinone, Propylene Glycol, Tocopheryl Acetate, Water

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label
label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1488306menthol 6 % Topical CreamPSN10
1488306menthol 60 MG/ML Topical CreamSCD10
1488306menthol 6 % Topical CreamSY10

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40104-381-01rocksauce ice1 in 1 PACKAGECREAM110
40104-381-01rocksauce ice88.7 mL in 1 BOTTLECREAM88.710
40104-381-02rocksauce ice1 in 1 PACKAGECREAM110
40104-381-02rocksauce ice355 mL in 1 BOTTLECREAM35510

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40104-381ROCKSAUCE ICE (MENTHOL) CREAM [NINGBO PULISI DAILY CHEMICAL PRODUCTS CO.,LTD.]10Legacy NDC, 4 package rows20171207_5c50c477-2849-435d-a5a7-f191d8842e77.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
40104-38140104-381-01, 40104-381-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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
0de8ccd1-365f-49dd-86c5-26b27be18ee35c50c477-2849-435d-a5a7-f191d8842e772017-12-07WarningsExact identifier
spl id: 0de8ccd1-365f-49dd-86c5-26b27be18ee3
spl set id: 5c50c477-2849-435d-a5a7-f191d8842e77

Reported adverse events (FAERS/openFDA)#

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