OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS.
Zinc undercylenate 18%
undecylenic acid 5%
ACTIVE INGREDIENTS.
Zinc undercylenate 18%
undecylenic acid 5%
PURPOSE
Antifungal
USES
For the treatment of athlete's foot. Relieves itching-scaling-cracking-buring.
AVOID CONTACT WITH EYES
Keep this and all drugs out od the reach of children. In case of accidental ingestion. seel professional assistance or contact a poison control center immediately.
Do not use in pregnancy and children under 2 years of age unless directed by a physician.
For external use only
In case of accidental ingestion seek professional assistance or contac a poison control center immediately.
Wash the affected area and dry throughly. Appy a thin layer of the product over the affected area ttwice daily ( morning and night) or as directed by a physician. Supervise children in the use of this product Pay special attention to space between the toes, wear well fitting, ventilated shoes. Change shoes and socks at least once daily. Use daily for 4 weeks. If condition persists, consults a physician.
This product is not effective on the scalp or nails.
Polyethylene Glyctol 500, polythylene glycol 4000, water, glycerin, cetyl alcohol, propylene, gycol, zinc stearate, nonyl phenol sulfate, sodium bisulfite.
KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN
Wash the affected area and dry throughly. Appy a thin layer of the product over the affected area ttwice daily ( morning and night) or as directed by a physician. Supervise children in the use of this product Pay special attention to space between the toes, wear well fitting, ventilated shoes. Change shoes and socks at least once daily. Use daily for 4 weeks. If condition persists, consults a physician.
This product is not effective on the scalp or nails
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1435159 | Derman Antifungal 5 % / 18 % Topical Cream | PSN | 2 |
| 1435154 | undecylenic acid 5 % / zinc undecylenate 18 % Topical Cream | PSN | 2 |
| 1435159 | undecylenic acid 50 MG/ML / zinc undecylenate 180 MG/ML Topical Cream [Derman] | SBD | 2 |
| 1435154 | undecylenic acid 50 MG/ML / zinc undecylenate 180 MG/ML Topical Cream | SCD | 2 |
| 1435159 | Derman Antifungal (undecylenic acid 5 % / zinc undecylenate 18 % ) Topical Cream | SY | 2 |
| 1435154 | undecylenic acid 5 % / zinc undecylenate 18 % Topical Cream | SY | 2 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69772-125-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-206d-f424-e053-dadaa90a57ce | 15fd4cd0-3d68-33ea-e054-00144ff8d46c |
| 69772-125-03 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-206d-f424-e053-dadaa90a57ce | 15fd4cd0-3d68-33ea-e054-00144ff8d46c |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69772-125-01 | DERMAN ANTIFUNGAL | 25 g in 1 TUBE | CREAM | 25 | 2 | |
| 69772-125-02 | DERMAN ANTIFUNGAL | 1 in 1 CARTON | CREAM | 1 | 2 | |
| 69772-125-03 | DERMAN ANTIFUNGAL | 50 g in 1 TUBE | CREAM | 50 | 2 | |
| 69772-125-03 | DERMAN ANTIFUNGAL | 1 in 1 CARTON | CREAM | 1 | 2 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| UNDECYLENIC ACID | ACTIVE INGREDIENT | K3D86KJ24N | 2 | |
| ZINC UNDECYLENATE | ACTIVE INGREDIENT | 388VZ25DUR | 2 | |
| UNDECYLENIC ACID | ACTIVE MOIETY | K3D86KJ24N | 2 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 2 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 2 | |
| POLYETHYLENE GLYCOL 4000 | INACTIVE INGREDIENT | 4R4HFI6D95 | 2 | |
| POLYETHYLENE GLYCOL 500 | INACTIVE INGREDIENT | 761NX2Q08Y | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 2 | |
| SODIUM BISULFITE | INACTIVE INGREDIENT | TZX5469Z6I | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 | |
| ZINC STEARATE | INACTIVE INGREDIENT | H92E6QA4FV | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69772-125 | 69772-125-01, 69772-125-02, 69772-125-03 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| UNDECYLENIC ACID | K3D86KJ24N | ACTIB |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| POLYETHYLENE GLYCOL 500 | 761NX2Q08Y | IACT |
| POLYETHYLENE GLYCOL 4000 | 4R4HFI6D95 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| CETYL ALCOHOL | 936JST6JCN | IACT |
| ZINC UNDECYLENATE | 388VZ25DUR | ACTIB |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| ZINC STEARATE | H92E6QA4FV | IACT |
| SODIUM BISULFITE | TZX5469Z6I | 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 |
|---|---|---|---|---|---|---|
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | GEL / TOPICAL | 24 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | ELIXIR / ORAL | 800 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | FILM, SOLUBLE / BUCCAL | 3 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM, SOLUBLE / BUCCAL | 5 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAVENOUS | 15 %w/v | ||
| POLYETHYLENE GLYCOL 4000 | POLYETHYLENE GLYCOL 4000 | 4R4HFI6D95 | SOLUTION / ORAL | 2667 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / INTRAVENOUS | 5 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | AEROSOL, FOAM / VAGINAL | 0.1 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / ORAL | 1 mg/1ml | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | OINTMENT / OPHTHALMIC | 0.05 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE, DENTIFRICE / DENTAL | 18 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | DROPS / ORAL | 200 mg/1ml | ||
| POLYETHYLENE GLYCOL 4000 | POLYETHYLENE GLYCOL 4000 | 4R4HFI6D95 | GRANULE / ORAL | 83 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / DENTAL | 20 %w/w | ||
| SODIUM BISULFITE | SODIUM BISULFITE | TZX5469Z6I | SOLUTION / OPHTHALMIC | 0.1 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | ELIXIR / ORAL | 5621 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SWAB / TOPICAL | 34.6 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / VAGINAL | 6.4 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CONCENTRATE / ORAL | 12 mg | ||
| ZINC STEARATE | ZINC STEARATE | H92E6QA4FV | CAPSULE / ORAL | 2.04 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRALESIONAL | 0.15 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUPPOSITORY / VAGINAL | NA | ||
| ZINC STEARATE | ZINC STEARATE | H92E6QA4FV | TABLET / SUBLINGUAL | 2.5 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYRUP / ORAL | 16734 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERINEURAL | 80 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / SUBCUTANEOUS | 1.4 %w/v | ||
| SODIUM BISULFITE | SODIUM BISULFITE | TZX5469Z6I | SOLUTION / ORAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / VAGINAL | 60 mg | ||
| SODIUM BISULFITE | SODIUM BISULFITE | TZX5469Z6I | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 51.8 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / RESPIRATORY (INHALATION) | 5 %w/w | ||
| SODIUM BISULFITE | SODIUM BISULFITE | TZX5469Z6I | INJECTION / SOFT TISSUE | 0.1 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INFILTRATION | 80 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED / ORAL | 96 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / TOPICAL | 5148 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SHAMPOO / TOPICAL | 8 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION, EXTENDED RELEASE / ORAL | 1000 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | AEROSOL, FOAM / TOPICAL | 0.16 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| POLYETHYLENE GLYCOL 4000 | POLYETHYLENE GLYCOL 4000 | 4R4HFI6D95 | INJECTION / INTRAMUSCULAR | 3 %w/v | ||
| SODIUM BISULFITE | SODIUM BISULFITE | TZX5469Z6I | DROPS / OPHTHALMIC | 0.06 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / ORAL | 27120 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, EMULSION / INTRAVENOUS | 24100 mg | ||
| ZINC STEARATE | ZINC STEARATE | H92E6QA4FV | SHAMPOO / TOPICAL | 2 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / OPHTHALMIC | 58 mg | ||
| POLYETHYLENE GLYCOL 4000 | POLYETHYLENE GLYCOL 4000 | 4R4HFI6D95 | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 375 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET, EXTENDED RELEASE / ORAL | 132 mg | ||
| ZINC STEARATE | ZINC STEARATE | H92E6QA4FV | TABLET, COATED / ORAL | 1.82 mg | ||
| SODIUM BISULFITE | SODIUM BISULFITE | TZX5469Z6I | INJECTION, SOLUTION / INTRAVENOUS | 0.05 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / TOPICAL | 76000 mg | ||
| ZINC STEARATE | ZINC STEARATE | H92E6QA4FV | TABLET / BUCCAL | 2.5 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAVENOUS | 4000 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUPPOSITORY / VAGINAL | 252 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | CREAM / VAGINAL | 200 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / AURICULAR (OTIC) | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | LOTION / TOPICAL | 1140 mg | ||
| SODIUM BISULFITE | SODIUM BISULFITE | TZX5469Z6I | CREAM / TOPICAL | 0.3 %w/w | ||
| SODIUM BISULFITE | SODIUM BISULFITE | TZX5469Z6I | INHALANT / RESPIRATORY (INHALATION) | NA |
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 |
|---|---|---|---|---|---|---|
| 1686d03c-efbb-6d6e-e054-00144ff88e88 | 15fd4cd0-3d68-33ea-e054-00144ff8d46c | 2015-05-20 | Warnings | 1686d03c-efbb-6d6e-e054-00144ff88e88 15fd4cd0-3d68-33ea-e054-00144ff8d46c |
Adverse event summaries are temporarily unavailable. Other product information remains available.