Label: ANTIPHLAMINE COIN PLASTER (methyl salicylate(kp) 5.541mg, l-menthol(kp), 2.769mg, dl-camphor(kp), 1.108mg, mentha oil(kp) 0.693mg, tocopherol acetate(kp) 0.308mg, diphenhydramine(kp) 0.246mg, vanillyl nonylamide- in-house 0.046mg patch

  • 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 May 11, 2017

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient: Methyl salicylate(KP) 5.541mg, L-menthol(KP), 2.769mg, dl-camphor(KP), 1.108mg, Mentha Oil(KP) 0.693mg, Tocopherol Acetate(KP) 0.308mg, Diphenhydramine(KP) 0.246mg, Vanillyl nonylamide(In-house) 0.046mg

  • INACTIVE INGREDIENT

    [Inactive Ingredients] Hydrogenated C6-20 Polyolefin, Styrene isoprene styrene block copolymer, Liquid paraffin, Polyisobutylene, Butylated hydroxytoluene, Non-woven fabric, Polyethylene terephthalate separator

  • PURPOSE

    [Purpose] Topical Analgesic

  • Warnings and Precautions

    [Warnings and Precautions] 1. Do not use to following patients 1) Children under 30 months 2) Patients with wounds or damaged skin cause by eczema or poison ivy

    2. Use carefully when using to following patients 1) Patients who have a history of allergic reaction to any drug or cosmetics 2) Patients who are allergic or whose family is allergic 3) Patients with severe moistness or erosion 4) Patients who are under a doctor's cure 5) Infant (Convulsions may occur)

    3. Side effects 1) Stop using and ask doctor or pharmacist if rash, redness, itching, or edema occurs. 2) Stop using if sometimes severe itching or pain occurs.

    4. General Precautions 1) Follow the given dosage and administration. 2) Use under adult's care for children. 3) Stop using and ask doctor or pharmacist if there is no improvement of symptoms in 5~6 days of using.

    5. Precautions for application 1) For external use only. 2) Use after wiping if the affected part is wet. 3) Do not heat the affected part with electric blanket or any. 4) Do not take a bath with this drug attached. Remove it 30 min~1 hour before bath.

    6. Precautions for storage 1) Keep out of the reach of children. 2) Store in a cool place out of direct sunlight, and keep it sealed. 3) Avoid misuse and do not put this product in a separate container for preservation of quality.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Indications

    [Indications] Anti-inflammatory effect to following symptoms: Bruise, wrick, muscle pain, arthralgia, backache, shoulder pain, neuralgia, and rheumatic pain.

  • DOSAGE & ADMINISTRATION

    [Dosage and Administration] Put the product on the affected part, one~several sheets daily

  • OTHER SAFETY INFORMATION

    [Description] Coin-shaped plaster with semitransparent cohesive substance applied on non-woven fabric.

    [Storage] Store in tight container at room temperature(1~30℃)

    [Package] 84 Sheets (42 Sheets X 2)

    [Safe Administration] 1. If attached to dry or delicate skin, use lukewarm water when removing. 2. If attached to sun-exposed part, you can prevent extraordinary skin reaction by covering the part with a bandage or clothes. 3. Avoid using it to the same part continuously to prevent skin allergy. Stop using if itching, rash, or redness occurs. 4. Take care to avoid using before and after taking a sauna or hot massage.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    ANTIPHLAMINE  COIN PLASTER
    methyl salicylate(kp) 5.541mg, l-menthol(kp), 2.769mg, dl-camphor(kp), 1.108mg, mentha oil(kp) 0.693mg, tocopherol acetate(kp) 0.308mg, diphenhydramine(kp) 0.246mg, vanillyl nonylamide(in-house) 0.046mg patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69642-1600
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL2.769 mg  in 0.2832 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)1.108 mg  in 0.2832 g
    Diphenhydramine (UNII: 8GTS82S83M) (DIPHENHYDRAMINE - UNII:8GTS82S83M) Diphenhydramine0.246 mg  in 0.2832 g
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-0.308 mg  in 0.2832 g
    Methyl Salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) Methyl Salicylate5.541 mg  in 0.2832 g
    Peppermint oil (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT0.693 mg  in 0.2832 g
    Nonivamide (UNII: S846B891OR) (NONIVAMIDE - UNII:S846B891OR) Nonivamide0.046 mg  in 0.2832 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69642-1600-284 in 1 CARTON10/10/2016
    1NDC:69642-1600-10.2832 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/10/2016
    Labeler - Hanul Trading Co., Ltd. (689512982)
    Registrant - Hanul Trading Co., Ltd. (689512982)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hanul Trading Co., Ltd.689512982relabel(69642-1600)
    Establishment
    NameAddressID/FEIBusiness Operations
    DAE HWA PHARMACEUTICAL CO., LTD.688004324manufacture(69642-1600)
    Establishment
    NameAddressID/FEIBusiness Operations
    KOCO TRADING CO., INC.079457993repack(69642-1600)