Medipap Cool: Package Insert and Label Information

MEDIPAP COOL- levomenthol patch
Cho-A Pharm.Co.,Ltd.

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.

Active ingredients

L-Menthol (20mg/11.7g)

Purpose

External analgesic

Uses

For the temporarily relief of minor aches and pains of muscles and joints associated with:

  • Arthritis
  • Simple backache
  • Strains
  • Bruises
  • Sprains

Directions

Adults and children 12 years of age and over:

  • Clean and dry affected area
  • Remove patch from film
  • Apply to affected area no more than 3 to 4 times daily for 7 days
  • Remove patch from skin after at most 8 hours’ application

Children undress 12 years of age: consult a doctor

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

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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

medical cool
(click image for full-size original)

MEDIPAP COOL
l-menthol patch
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58354-107
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOMENTHOL (LEVOMENTHOL) LEVOMENTHOL 20 mg in 11.7 g
Inactive Ingredients
Ingredient Name Strength
FELBINAC
PROPYLPARABEN
DIISOPROPANOLAMINE
TITANIUM DIOXIDE
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 1200 MPA.S AT 1%)
SODIUM POLYACRYLATE (2500000 MW)
TARTARIC ACID
BUTYLATED HYDROXYTOLUENE
METHYLPARABEN
DIPROPYLENE GLYCOL
PROPYLENE GLYCOL MONOLAURATE
KAOLIN
GELATIN
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58354-107-02 5 PATCH in 1 POUCH contains a PATCH (58354-107-01)
1 NDC:58354-107-01 11.7 g in 1 PATCH This package is contained within the POUCH (58354-107-02)
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 Operations
Cho-A Pharm.Co.,Ltd. 688056831 manufacture (58354-107)

Revised: 12/2019 Cho-A Pharm.Co.,Ltd.

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