FUCIDIN- sodium fusidate ointment 
I World Pharmaceutical 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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Sodium Fusidate

temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, poison ivy, poison oak, or poison sumac soaps detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, external genital and anal itching

Keep out of reach of children

Adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily

For external use only.

Do not use in the eyes by putting this product into the rectum by using fingers or any mechanical device or applicator.

Ask a doctor before use if you have a vaginal discharge, rectal bleeding, diaper rash.

When using this product consult a doctor before exceeding recommended dosage.

Stop use and ask a doctor if condition gets worse, condition persists for more than 7 days, condition clears up and occurs again with within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

cetostearyl alcohol, propylene glycol, purified water, sodium lauryl sulfate, white petrolatum

For topical use only

label

FUCIDIN 
sodium fusidate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73442-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FUSIDATE SODIUM (UNII: J7P3696BCQ) (FUSIDIC ACID - UNII:59XE10C19C) FUSIDIC ACID20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73442-0001-110 g in 1 TUBE; Type 0: Not a Combination Product10/08/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/08/2019
Labeler - I World Pharmaceutical Co., Ltd. (688222857)
Registrant - I World Pharmaceutical Co., Ltd. (688222857)
Establishment
NameAddressID/FEIBusiness Operations
I World Pharmaceutical Co., Ltd.688222857manufacture(73442-0001)

Revised: 11/2019
Document Id: 96b7b864-2571-8570-e053-2995a90a176b
Set id: 96b7b841-0954-85a2-e053-2995a90aafdf
Version: 1
Effective Time: 20191106
 
I World Pharmaceutical Co., Ltd.