Label: MEDIPAP COOL- l-menthol patch
- NDC Code(s): 58354-107-01, 58354-107-02
- Packager: Cho-A Pharm.Co.,Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated December 31, 2019
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Directions
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Warnings
For external use only
Do not use
- on wounds or damaged skin
- if you are allergic to any ingredients of this product
- with a heating pad
- with, or at the same time as, other external analgesic products
When using this product
- do not use otherwise than directed
- avoid contact with eyes, mucous membranes or rashes
- do not bandage tightly
Ask a doctor before use if you are prone to allergic reaction from aspirin or salicylates
Stop use and ask a doctor if
- rash, itching, or excessive skin irritation develops
- conditions worsen
- symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
If pregnant or breast-feeding, ask a health professional before use.
- Keep out of reach of children
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Inactive ingredients
Felbinac, Methylparaben, Propylparaben, Diisopropanolamine, Dipropylene Glycol, Propylene Glycol Monolaurate, Conc. Glycerin, Titanium Oxide, Kaolin, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate Hydrate, Disodium Edetate Hydrate, Sodium Polyacrylate, Gelatin, Carbomer Solution, Tartaric Acid, Ferric Oxide, Butylhydroxytoluene, Purified Water
- Medipap Cool
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INGREDIENTS AND APPEARANCE
MEDIPAP COOL
l-menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58354-107 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL 20 mg in 11.7 g Inactive Ingredients Ingredient Name Strength FELBINAC (UNII: 94WNJ5U8L7) PROPYLPARABEN (UNII: Z8IX2SC1OH) DIISOPROPANOLAMINE (UNII: 0W44HYL8T5) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 1200 MPA.S AT 1%) (UNII: 4J4P6L645M) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) TARTARIC ACID (UNII: W4888I119H) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) METHYLPARABEN (UNII: A2I8C7HI9T) DIPROPYLENE GLYCOL (UNII: E107L85C40) PROPYLENE GLYCOL MONOLAURATE (UNII: 668Z5835Z3) KAOLIN (UNII: 24H4NWX5CO) GELATIN (UNII: 2G86QN327L) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58354-107-02 5 in 1 POUCH 02/21/2018 1 NDC:58354-107-01 11.7 g in 1 PATCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/21/2018 Labeler - Cho-A Pharm.Co.,Ltd. (688056831) Registrant - Cho-A Pharm.Co.,Ltd. (688056831) Establishment Name Address ID/FEI Business Operations Cho-A Pharm.Co.,Ltd. 688056831 manufacture(58354-107)