ANTIPHLAMINE PAIN RELIEVING- flurbiprofen patch 
HANUL TRADING CO., LTD.

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.

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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

Image of cello pack

ANTIPHLAMINE PAIN RELIEVING 
flurbiprofen patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69642-1300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Flurbiprofen (UNII: 5GRO578KLP) (FLURBIPROFEN - UNII:5GRO578KLP) Flurbiprofen33 mg  in 5 
Inactive Ingredients
Ingredient NameStrength
Methylparaben (UNII: A2I8C7HI9T)  
Propylparaben (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69642-1300-15 in 1 CELLO PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/01/2015
Labeler - HANUL TRADING CO., LTD. (689512982)
Registrant - HANUL TRADING CO., LTD. (689512982)
Establishment
NameAddressID/FEIBusiness Operations
HANUL TRADING CO., LTD.689512982repack(69642-1300)
Establishment
NameAddressID/FEIBusiness Operations
Dae Hwa Pharm Co., Ltd.688004324manufacture(69642-1300)
Establishment
NameAddressID/FEIBusiness Operations
KOCO TRADING CO., INC.079457993wholesale drug distributor(69642-1300)

Revised: 10/2015
Document Id: 59931787-286d-4bb8-a96b-dbc916366521
Set id: c89637f8-93e5-4d6d-bffc-536e800bb07f
Version: 1
Effective Time: 20151013
 
HANUL TRADING CO., LTD.