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
Drug Label Information
Updated October 19, 2023
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- Official Label (Printer Friendly)
- Purpose Section
- Warnings
- Dosage
- Directions
- Stop use and ask doctor
- Storage
- KEEP OUT OF REACH OF CHILDREN
- Active Ingredient section
- Inactive Ingredient section
- Carton
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INGREDIENTS AND APPEARANCE
TEMPO COOL
menthol patchProduct 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 Drug M017 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)