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
Contains inactivated NDC Code(s)
NDC Code(s): 69642-1600-1, 69642-1600-2
- Packager: Hanul Trading 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.
Updated May 11, 2017
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
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
- DOSAGE & ADMINISTRATION
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
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 Type HUMAN OTC DRUG Item Code (Source) NDC:69642-1600 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL 2.769 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) Diphenhydramine 0.246 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 Salicylate 5.541 mg in 0.2832 g Peppermint oil (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT 0.693 mg in 0.2832 g Nonivamide (UNII: S846B891OR) (NONIVAMIDE - UNII:S846B891OR) Nonivamide 0.046 mg in 0.2832 g Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69642-1600-2 84 in 1 CARTON 10/10/2016 1 NDC:69642-1600-1 0.2832 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 10/10/2016 Labeler - Hanul Trading Co., Ltd. (689512982) Registrant - Hanul Trading Co., Ltd. (689512982) Establishment Name Address ID/FEI Business Operations Hanul Trading Co., Ltd. 689512982 relabel(69642-1600) Establishment Name Address ID/FEI Business Operations DAE HWA PHARMACEUTICAL CO., LTD. 688004324 manufacture(69642-1600) Establishment Name Address ID/FEI Business Operations KOCO TRADING CO., INC. 079457993 repack(69642-1600)