Antiphlamine

Manufacturer
Hanul Trading Co., Ltd. | DAE HWA PHARMACEUTICAL CO., LTD. | KOCO TRADING CO., INC.
Effective date
2017-05-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:49:50

Label at a glance#

ProductAntiphlamine Coin Plaster
Active ingredientLEVOMENTHOL, CAMPHOR (SYNTHETIC), Diphenhydramine, .ALPHA.-TOCOPHEROL, DL-, Methyl Salicylate, Peppermint oil, Nonivamide
Label structure9 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

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 INGREDIENT SECTION

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

PURPOSE

OTC - PURPOSE SECTION

[Purpose] Topical Analgesic

Warnings and Precautions

WARNINGS SECTION

[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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Indications

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

[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 cartonImage of carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
PEPPERMINT Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69642-1600-22020-01-31C16284748780-19d75b9cf-d2d1-f424-e053-dadaa90a57cef165da5c-a6dc-4246-b8a3-a87fdb86caa5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69642-1600-1AntiphlamineCoin Plaster0.2832 g in 1 PATCHPATCH0.28322
69642-1600-2AntiphlamineCoin Plaster84 in 1 CARTONPATCH842

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69642-1600ANTIPHLAMINE 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 [HANUL TRADING CO., LTD.]2Legacy NDC, 2 package rows20170511_f165da5c-a6dc-4246-b8a3-a87fdb86caa5.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69642-160069642-1600-1, 69642-1600-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b7b9a4a2-c08f-4db0-bf2e-2e5a2ab09c4ff165da5c-a6dc-4246-b8a3-a87fdb86caa52017-05-11WarningsExact identifier
spl id: b7b9a4a2-c08f-4db0-bf2e-2e5a2ab09c4f
spl set id: f165da5c-a6dc-4246-b8a3-a87fdb86caa5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.