OTC - ACTIVE INGREDIENT SECTION
Active ingredient Purpose
Undecylenic acid 25% w/v.......Antifungal
Section from Directions portion of carton label follows:
Directions
- Using soap and water, clean the
affected area and dry thoroughly
- apply a thin layer of the product over
affected area twice daily (morning and
night) or as directed by a doctor.
- Use the brush applicator provided for
easy application to the affected area
- For toe usage, change shoes and socks
at least once daily and wear well fitting,
ventilated shoes
- Pay particular attention to spaces
between the toes for athletes foot
- For athletes foot and ringworm, use the
product daily for 4 weeks. If condition
persists longer, consult a physician
- This product is not effective on the scalp
or nails
- Children must be supervised in the use
of this product
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49035-987-74 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-bf8d-8e05-e053-dbdaa90a074a | drug facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49035-987-74 | UNDECYLENIC ACID | 30 mL in 1 BOTTLE, WITH APPLICATOR | LIQUID | 30 | 8 | |
| 49035-987-74 | UNDECYLENIC ACID | 1 in 1 CARTON | LIQUID | 1 | 8 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| UNDECYLENIC ACID | ACTIVE INGREDIENT | K3D86KJ24N | 8 | |
| UNDECYLENIC ACID | ACTIVE MOIETY | K3D86KJ24N | 8 | |
| ISOPROPYL PALMITATE | INACTIVE INGREDIENT | 8CRQ2TH63M | 8 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 49035-987 | 49035-987-74 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| UNDECYLENIC ACID | K3D86KJ24N | ACTIB |
| ISOPROPYL PALMITATE | 8CRQ2TH63M | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| ISOPROPYL PALMITATE | ISOPROPYL PALMITATE | 8CRQ2TH63M | AEROSOL / TOPICAL | 397 mg | ||
| ISOPROPYL PALMITATE | ISOPROPYL PALMITATE | 8CRQ2TH63M | AEROSOL, SPRAY / TOPICAL | 397 mg | ||
| ISOPROPYL PALMITATE | ISOPROPYL PALMITATE | 8CRQ2TH63M | LOTION / TOPICAL | 5 %w/w | ||
| ISOPROPYL PALMITATE | ISOPROPYL PALMITATE | 8CRQ2TH63M | GEL / TOPICAL | NA | ||
| ISOPROPYL PALMITATE | ISOPROPYL PALMITATE | 8CRQ2TH63M | FILM / TRANSDERMAL | 2 mg | ||
| ISOPROPYL PALMITATE | ISOPROPYL PALMITATE | 8CRQ2TH63M | OINTMENT / TOPICAL | NA | ||
| ISOPROPYL PALMITATE | ISOPROPYL PALMITATE | 8CRQ2TH63M | FILM, EXTENDED RELEASE / TRANSDERMAL | 187.5 mg | ||
| ISOPROPYL PALMITATE | ISOPROPYL PALMITATE | 8CRQ2TH63M | CREAM / TOPICAL | 112 mg |
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 |
|---|---|---|---|---|---|---|
| c7e441a0-026e-4646-9b88-a1b9c34f07a5 | eaedf82d-2fae-4360-8a88-f2f62ae9a18c | 2011-02-04 | Warnings | c7e441a0-026e-4646-9b88-a1b9c34f07a5 eaedf82d-2fae-4360-8a88-f2f62ae9a18c |
Adverse event summaries are temporarily unavailable. Other product information remains available.