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

Antiphlamine by

Drug Labeling and Warnings

Antiphlamine by is a Otc medication manufactured, distributed, or labeled by Hanul Trading Co., Ltd., DAE HWA PHARMACEUTICAL CO., LTD., KOCO TRADING CO., INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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)