OTC - ACTIVE INGREDIENT SECTION
Sodium Fusidate
FUCIDIN
- Manufacturer
- Lydia Co., Ltd. | I World Pharmaceutical Co., Ltd.
- Effective date
- 2019-10-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:00:45
Label at a glance#
ProductFUCIDIN
Active ingredientFUSIDATE SODIUM
Label structure8 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
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
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
INDICATIONS & USAGE SECTION
Adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily
WARNINGS SECTION
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.
INACTIVE INGREDIENT SECTION
cetostearyl alcohol, propylene glycol, purified water, sodium lauryl sulfate, white petrolatum
DOSAGE & ADMINISTRATION SECTION
For topical use only
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 72988-0015-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1f46-a910-e053-dadaa90a0b85 | 94586c4c-da34-47e0-e053-2a95a90a144c |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72988-0015-1 | FUCIDIN | 10 g in 1 TUBE | OINTMENT | 10 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 72988-0015 | FUCIDIN (SODIUM FUSIDATE) OINTMENT [LYDIA CO., LTD.] | 1 | Legacy NDC, 1 package rows | 20191008_94586c4c-da34-47e0-e053-2a95a90a144c.zip |
Products#
Every source-derived product name is available through these pages.
- FUCIDIN
- Sodium Fusidate
- DIPROPYLENE GLYCOL
- CETOSTEARYL ALCOHOL
- SODIUM LAURYL SULFATE
- FUSIDATE SODIUM
- FUSIDIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72988-0015 | 72988-0015-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DIPROPYLENE GLYCOL | E107L85C40 | IACT |
| CETOSTEARYL ALCOHOL | 2DMT128M1S | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| FUSIDATE SODIUM | J7P3696BCQ | ACTIM |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 94587991-bc94-fcfd-e053-2995a90af86a | 94586c4c-da34-47e0-e053-2a95a90a144c | 2019-10-07 | Warnings | 94587991-bc94-fcfd-e053-2995a90af86a 94586c4c-da34-47e0-e053-2a95a90a144c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.