FDA.reportPublic FDA data

Cold and Heat Pain Relieving Cream

Manufacturer
SOTAC PHARMACEUTICALS PRIVATE LIMITED
Effective date
2018-08-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:56:33

Label at a glance#

ProductCold and Heat Pain Relieving Cream
Active ingredientMENTHOL, METHYL SALICYLATE
Label structure8 sections

Indications and uses

temporarily relieves minor pain associated with: arthritis simple backache muscle strains sprains bruises cramps

Dosage and administration

adults and children over 12 years: apply generously to affected area massage into painful area until thoroughly absorbed into skin repeat as necessary, but not more than 4 times daily children 12 years or younger: ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 10%

Methyl salicylate 30%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
  • cramps

Warnings

WARNINGS SECTION

For external use only

SEE INSIDE LABEL FOR COMPLETE DRUG FACTS

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

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes or mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health care professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children over 12 years:

  • apply generously to affected area
  • massage into painful area until thoroughly absorbed into skin
  • repeat as necessary, but not more than 4 times daily

children 12 years or younger: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

ceresin, cyclomethicone, hydrogenated castor oil, microcrystalline wax, paraffin, PEG-150 distearate, propylene glycol, stearic acid, stearyl alcohol (245-111)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

76168-402-44 (1)76168-402-44 (1)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311500menthol 10 % / methyl salicylate 30 % Topical CreamPSN2
311500menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCD2
311500menthol 10 % / methyl salicylate 30 % Topical CreamSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130376168402445GTIN-13: 0376168402445
EAN-13: 0376168402445
GTIN-12: 376168402445
UPC-A: 376168402445
GTIN storage (14 digits): 00376168402445		76168-402-44 (1).jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72351-010-002021-01-29C16284748780-1ba0f9c33-41dc-a910-e053-dadaa90a0b85Cold and Heat Pain Relieving Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72351-010-00Cold and Heat Pain Relieving Cream208 g in 1 BOXCREAM2082

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72351-010COLD AND HEAT PAIN RELIEVING CREAM (MENTHOL AND METHYL SALICYLATE) CREAM [SOTAC PHARMACEUTICALS PRIVATE LIMITED]2Legacy NDC, 1 package rows20180809_0e17401b-2992-4203-9ebf-b49b5d7dd3e5.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72351-01072351-010-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETYL ESTERS WAXD072FFP9GUIACT
OLETH-3 PHOSPHATE8Q0Z18J1VLIACT
STEARIC ACID4ELV7Z65APIACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
MENTHOLL7T10EIP3AACTIB
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
73052b31-40f7-2f3f-e053-2a91aa0a9de10e17401b-2992-4203-9ebf-b49b5d7dd3e52018-08-09WarningsExact identifier
spl id: 73052b31-40f7-2f3f-e053-2a91aa0a9de1
spl set id: 0e17401b-2992-4203-9ebf-b49b5d7dd3e5

Reported adverse events (FAERS/openFDA)#

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