TEMPO COOL- menthol patch
The Egyptian Saudi Co. For Medical Manufacturing (Masco-Mid) S.A.E

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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TempoCOOL

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

TEMPO COOL
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72602-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3 mg in 1 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	1 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TARTARIC ACID (UNII: W4888I119H)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CARBOXYMETHYLCELLULOSE SODIUM (0.9 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 600 MPA.S AT 2%) (UNII: ZY4732LP1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLYACRYLIC ACID (800000 MW) (UNII: D0I6NSZ87U)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72602-003-01	3 g in 1 PATCH; Type 0: Not a Combination Product	09/21/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	09/20/2018

Labeler - The Egyptian Saudi Co. For Medical Manufacturing (Masco-Mid) S.A.E (850486280)

Registrant - The Egyptian Saudi Co. For Medical Manufacturing (Masco-Mid) S.A.E (850486280)

Name	Address	ID/FEI	Business Operations
Establishment
The Egyptian Saudi Co. For Medical Manufacturing (Masco-Mid) S.A.E		850486280	manufacture(72602-003)

Revised: 12/2021

Document Id: d2a2948b-7da0-2712-e053-2995a90a1266

Set id: bd642389-6d03-4e09-a71c-312fb90eae89

Version: 3

Effective Time: 20211208

The Egyptian Saudi Co. For Medical Manufacturing (Masco-Mid) S.A.E