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| Product NDC Code | 72602-003 | ||||
|---|---|---|---|---|---|
| Drug Name | Tempo cool |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PATCH | ||||
| Application Number | M017 | ||||
| Labeler Name | The Egyptian Saudi Co. For Medical Manufacturing (Masco-Mid) S.A.E | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient section Menthol 0.3 % Camphor. 1%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Dosage One sheet for 8 hours.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredient section Glycerin ,Sodium polyacrylate , Anhydrous citric acid ,Tartaric acid ,Poly sorbate -80 (tween 80) , EDETA ,Water.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Directions Peel off the transparent layer,attach Sheet to the forehead area or back of the neck.
Purpose
Information about the drug product’s indications for use.Purpose Section Children suffering from high temperature or fever Adults suffering from headache and migrain
Spl product data elements
Usually a list of ingredients in a drug product.Tempo cool Menthol GLYCERIN SODIUM POLYACRYLATE (2500000 MW) CITRIC ACID MONOHYDRATE TARTARIC ACID POLYSORBATE 80 CARBOXYMETHYLCELLULOSE SODIUM (0.9 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 600 MPA.S AT 2%) EDETATE DISODIUM POLYACRYLIC ACID (800000 MW) WATER MENTHOL MENTHOL CAMPHOR (NATURAL) CAMPHOR (NATURAL)
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Carton Carton
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Stop use and ask doctor If condition worsens
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right a way
Storage and handling
Information about safe storage and handling of the drug product.Storage Store in a cool dry place. Avoid direct sunlight.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API