Label: TEMPO COOL- menthol patch

  • NDC Code(s): 72602-003-01
  • Packager: The Egyptian Saudi Co. For Medical Manufacturing (Masco-Mid) S.A.E
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 19, 2023

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  • 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

  • INGREDIENTS AND APPEARANCE
    TEMPO COOL 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72602-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 mg  in 1 g
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72602-003-013 g in 1 PATCH; Type 0: Not a Combination Product09/21/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01709/20/2018
    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
    NameAddressID/FEIBusiness Operations
    The Egyptian Saudi Co. For Medical Manufacturing (Masco-Mid) S.A.E850486280manufacture(72602-003)
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