FDA.reportPublic FDA data

Tempo cool

Manufacturer
The Egyptian Saudi Co. For Medical Manufacturing (Masco-Mid) S.A.E
Effective date
2025-10-06
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:18:57

Label at a glance#

ProductTempo cool
Active ingredientMENTHOL, CAMPHOR (NATURAL)
Label structure10 sections

Dosage and administration

Peel off the transparent layer,attach Sheet to the forehead area or back of the neck.

Storage and handling

Store in a cool dry place. Avoid direct sunlight.

Label contents#

Full prescribing information#

Purpose Section

OTC - PURPOSE SECTION

  • Children suffering from high temperature or fever
  • Adults suffering from headache and migrain

Warnings

WARNINGS SECTION

  • FOR EXTERNAL USE ONLY
  • Tempo cool has no side effects and used safely with all medications.
  • Avoid contacts with eyes.
  • Do not bandage tightly.
  • Do not apply to wound or damaged skin

Dosage

DOSAGE & ADMINISTRATION SECTION

  • One sheet for 8 hours.

Directions

INDICATIONS & USAGE SECTION

  • Peel off the transparent layer,attach Sheet to the forehead area or back of the neck.

Stop use and ask doctor

OTC - ASK DOCTOR SECTION

  • If condition worsens

Storage

STORAGE AND HANDLING SECTION

  • Store in a cool dry place.
  • Avoid direct sunlight.

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 a way

Active Ingredient section

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.3 %

Camphor. 1%

Inactive Ingredient section

Glycerin ,Sodium polyacrylate , Anhydrous citric acid  ,Tartaric acid ,Poly sorbate -80 (tween 80) ,
EDETA ,Water.

Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72602-003-012021-12-08C16284748780-1ba0f9c33-4c4c-a910-e053-dadaa90a0b85TempoCOOL
72602-003-012021-01-29C16284748780-1ba0f9c33-4c4c-a910-e053-dadaa90a0b85TempoCOOL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72602-003-01Tempo cool3 g in 1 PATCHPATCH36

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72602-00372602-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
TARTARIC ACIDW4888I119HIACT
POLYSORBATE 806OZP39ZG8HIACT
CARBOXYMETHYLCELLULOSE SODIUM (0.9 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 600 MPA.S AT 2%)ZY4732LP1OIACT
EDETATE DISODIUM7FLD91C86KIACT
POLYACRYLIC ACID (800000 MW)D0I6NSZ87UIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB
CAMPHOR (NATURAL)N20HL7Q941ACTIB

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
Tempo coolMENTHOLThe Egyptian Saudi Co. For Medical Manufacturing (Masco-Mid) S.A.Ebd642389-6d03-4e09-a71c-312fb90eae892025-10-06WarningsExact identifier
ndc (package): 72602-003-01
ndc (product): 72602-003
ndc11 (package): 72602000301
spl id: 40816000-b3bc-1f81-e063-6394a90abb65
spl set id: bd642389-6d03-4e09-a71c-312fb90eae89

Reported adverse events (FAERS/openFDA)#

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