Tempo Cool Patch
FDA Label NDC 72602-003

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Egyptian Saudi Co. For Medical Manufacturing (masco-mid) S.a.e for the product Tempo Cool (NDC 72602-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding purpose section, warnings, dosage, directions, stop use and ask doctor, storage, keep out of reach of children, active ingredient section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Purpose Section

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

Warnings

  • 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

  • One sheet for 8 hours.

Directions

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

Stop Use And Ask Doctor

  • If condition worsens

Storage

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

Keep Out Of Reach Of Children

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

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

Carton (Tempo Cool)

Carton (Tempo Cool)

* Please review the disclaimer below.