ANTIPHLAMINE PAIN RELIEVING- flurbiprofen patch

Antiphlamine Pain Relieving by

Drug Labeling and Warnings

Antiphlamine Pain Relieving by is a Otc medication manufactured, distributed, or labeled by HANUL TRADING CO., LTD., Dae Hwa Pharm Co., Ltd., KOCO TRADING CO., INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Flurbiprofen 33mg

INACTIVE INGREDIENT

Inactive Ingredients: Methylparaben, Propylparaben, L-menthol, Propylene Glycol, Glycerin, Titanium Oxide, Kaolin, Sodium Carboxymethyl Cellulose, Dihydroxyaluminum Aminoacetate Hydrate, Disodium Edetate Hydrate, Gelatin, Sodium Polyacrylate, Polyacrylic Acid solution, Ferric Oxide, Butylhydroxytoluene, Purified water, felt, attachment felt, Polyethyleneterephthalate Separator, propyleneglycol monocaprylate, Sorbitan Oleate, tartaric acid

PURPOSE

Purpose: Topical Analgesic

WARNINGS

Warnings: For external use only Ask a doctor before use if you have redness over the affected area. Do not use: on wounds or damaged skin. Stop use and ask a doctor if excessive skin irritation occurs. Do not use if you are pregnant or breast feading. Do not use if you are allergic to any of the ingredients(Aspirin, Flurbiprofen) and stop use if rash, itching or allergic reaction develops.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children: Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center immediately. Children under 12 years of age: Ask a doctor Children under 30 month: Do not use

INDICATIONS & USAGE

Indications & Usage: For the temporary relief of Shoulder Pain, Backache, Neuralgia, Arthralgia, Sore Muscles, Sprains, Bruises, Rheumatic Pain, and Fracture Pain.

DOSAGE & ADMINISTRATION

Dosage & Administration: Attach to the affected part, twice daily

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTIPHLAMINE PAIN RELIEVING 
flurbiprofen patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69642-1300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Flurbiprofen (UNII: 5GRO578KLP) (FLURBIPROFEN - UNII:5GRO578KLP)	Flurbiprofen	33 mg  in 5

Inactive Ingredients
Ingredient Name	Strength
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69642-1300-1	5 in 1 CELLO PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/01/2015

Labeler - HANUL TRADING CO., LTD. (689512982)

Registrant - HANUL TRADING CO., LTD. (689512982)

Establishment
Name	Address	ID/FEI	Business Operations
HANUL TRADING CO., LTD.		689512982	repack(69642-1300)

Establishment
Name	Address	ID/FEI	Business Operations
Dae Hwa Pharm Co., Ltd.		688004324	manufacture(69642-1300)

Establishment
Name	Address	ID/FEI	Business Operations
KOCO TRADING CO., INC.		079457993	wholesale drug distributor(69642-1300)