Indications and uses
Temporarily protects and helps relieve chapped or cracked skin
Temporarily protects and helps relieve chapped or cracked skin
Apply as needed
Store at room temperature
Drug Facts
Allantoin 1%
Skin Protectant
For external use only
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Store at room temperature
Water, PEG-4, Xanthan Gum, Alcohol, Allium Cepa (Onion) Bulb Extract, Fragrance, Methylparaben, Sorbic Acid, D&C Violet No. 2, FD&C Red No. 4.
For more information call 1-888-925-8989 or visit
www.mederma.com
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0259-1101-20 | 2022-02-25 | C162847 | 48780-1 | 9d75b9d0-e674-f424-e053-dadaa90a57ce | Mederma ® for Kids ™ |
| 0259-1101-20 | 2022-01-28 | C162847 | 48780-1 | 9d75b9d0-e674-f424-e053-dadaa90a57ce | Mederma ® for Kids ™ |
| 0259-1101-20 | 2020-02-07 | C162847 | 48780-1 | 9d75b9d0-e674-f424-e053-dadaa90a57ce | Mederma ® for Kids ™ |
| 0259-1101-20 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e674-f424-e053-dadaa90a57ce | Mederma ® for Kids ™ |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Allantoin | ACTIVE INGREDIENT | 344S277G0Z | 2 | |
| Allantoin | ACTIVE MOIETY | 344S277G0Z | 2 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | 2 | |
| EXT. D&C VIOLET NO. 2 | INACTIVE INGREDIENT | G5UX3K0728 | 2 | |
| FD&C RED NO. 4 | INACTIVE INGREDIENT | X3W0AM1JLX | 2 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 2 | |
| ONION | INACTIVE INGREDIENT | 492225Q21H | 2 | |
| POLYETHYLENE GLYCOL 200 | INACTIVE INGREDIENT | R95B8J264J | 2 | |
| SORBIC ACID | INACTIVE INGREDIENT | X045WJ989B | 2 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 2 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0259-1101 | 0259-1101-20 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Allantoin | 344S277G0Z | ACTIB |
| water | 059QF0KO0R | IACT |
| POLYETHYLENE GLYCOL 200 | R95B8J264J | IACT |
| ONION | 492225Q21H | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| SORBIC ACID | X045WJ989B | IACT |
| EXT. D&C VIOLET NO. 2 | G5UX3K0728 | IACT |
| FD&C RED NO. 4 | X3W0AM1JLX | 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 |
|---|---|---|---|---|---|---|
| SORBIC ACID | SORBIC ACID | X045WJ989B | TABLET, COATED / ORAL | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / AURICULAR (OTIC) | 0.01 %w/w | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | EMULSION / OPHTHALMIC | 1 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / ORAL | 6624 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / TOPICAL | 561 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | LOTION / TOPICAL | 0.3 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY, METERED / SUBLINGUAL | 29 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SWAB / TOPICAL | 2250 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / RESPIRATORY (INHALATION) | 0.03 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / TOPICAL | 0.24 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / DENTAL | 12.8 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUPPOSITORY / VAGINAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | FILM / BUCCAL | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SUSPENSION / SUBCUTANEOUS | 0.16 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | ELIXIR / ORAL | 13675 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, METERED / RESPIRATORY (INHALATION) | 26664 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | MOUTHWASH / BUCCAL | 200 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVENOUS | 99 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | POWDER, FOR SOLUTION / ORAL | 126 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / OPHTHALMIC | 0.5 %w/v | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | GEL / TOPICAL | 58 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TROCHE / ORAL | 948 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / ORAL | 1 mg/1ml | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET, CHEWABLE / ORAL | 1.28 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | AEROSOL, FOAM / TOPICAL | 6 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | OINTMENT / OPHTHALMIC | 0.05 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM / VAGINAL | 22 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRAMUSCULAR | 95 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SYRUP / ORAL | 21000 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | TABLET, DELAYED RELEASE / ORAL | 0.03 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | OINTMENT / TOPICAL | 29 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 6 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CAPSULE / ORAL | 882 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SHAMPOO / TOPICAL | 0.15 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / EPIDURAL | 1 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | SOLUTION/ DROPS / OPHTHALMIC | 0.2 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / TRANSDERMAL | 49.37 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRALESIONAL | 0.15 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERINEURAL | 80 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PARENTERAL | 18 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC | 0.6 %w/w | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET / ORAL | 56 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / AURICULAR (OTIC) | NA | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SUSPENSION / ORAL | 681 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / ORAL | 3563 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / TOPICAL | 9971 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | EMULSION / TOPICAL | 0.2 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET / ORAL | 1.8 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CAPSULE / ORAL | 7 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / INTRAVENOUS | 45 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / OPHTHALMIC | 0.01 %w/w | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | LOTION / TOPICAL | 4 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | JELLY / NASAL | 250 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / TRANSDERMAL | 7360 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / ORAL | 150.68 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | DROPS / ORAL | 210 mg/1ml | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / ORAL | 360 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | TABLET, DELAYED RELEASE / ORAL | 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 |
|---|---|---|---|---|---|---|
| a996c79d-4c17-42b1-9288-1d0aed0353a3 | d9bdf1c9-c9c5-4827-a273-a954ace4b1a5 | 2022-02-22 | Warnings | a996c79d-4c17-42b1-9288-1d0aed0353a3 d9bdf1c9-c9c5-4827-a273-a954ace4b1a5 |
Adverse event summaries are temporarily unavailable. Other product information remains available.