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Antiphlamine Coin Plaster

Medically reviewed on May 11, 2017

Dosage form: patch
Ingredients: LEVOMENTHOL 2.769mg in 0.2832g, CAMPHOR (SYNTHETIC) 1.108mg in 0.2832g, Diphenhydramine 0.246mg in 0.2832g, .ALPHA.-TOCOPHEROL, DL- 0.308mg in 0.2832g, Methyl Salicylate 5.541mg in 0.2832g, Peppermint oil 0.693mg in 0.2832g, Nonivamide 0.046mg in 0.2832g
Labeler: Hanul Trading Co., Ltd.
NDC Code: 69642-1600

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 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

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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOMENTHOL (LEVOMENTHOL) LEVOMENTHOL2.769 mg  in 0.2832 g
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)1.108 mg  in 0.2832 g
Diphenhydramine (DIPHENHYDRAMINE) Diphenhydramine0.246 mg  in 0.2832 g
.ALPHA.-TOCOPHEROL, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL-0.308 mg  in 0.2832 g
Methyl Salicylate (SALICYLIC ACID) Methyl Salicylate5.541 mg  in 0.2832 g
Peppermint oil (PEPPERMINT) PEPPERMINT0.693 mg  in 0.2832 g
Nonivamide (NONIVAMIDE) Nonivamide0.046 mg  in 0.2832 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL 
Packaging
#Item CodePackage Description
1NDC:69642-1600-284 PATCH in 1 CARTON
1NDC:69642-1600-10.2832 g in 1 PATCH
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/FEIOperations
Hanul Trading Co., Ltd.689512982relabel(69642-1600)
Establishment
NameAddressID/FEIOperations
DAE HWA PHARMACEUTICAL CO., LTD.688004324manufacture(69642-1600)
Establishment
NameAddressID/FEIOperations
KOCO TRADING CO., INC.079457993repack(69642-1600)

 
Hanul Trading Co., Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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