TEMPO COOL- menthol patch

Tempo cool by

Drug Labeling and Warnings

Tempo cool by is a Otc medication manufactured, distributed, or labeled by The Egyptian Saudi Co. For Medical Manufacturing (Masco-Mid) S.A.E. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

TEMPO COOL 
menthol patch

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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)

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