Indications and uses
for temporary reilef of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor irritation dries the oozing and weeping of poison ivy, poison oak and poison sumac.
for temporary reilef of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor irritation dries the oozing and weeping of poison ivy, poison oak and poison sumac.
Adults and children 2 years of age and older apply to affected area not more than 3 to 4 times daily Children under 2 years of age ask a doctor Do not use more often than directed
Pramoxine HCl 1%
Zinc Oxide 0.4%
Calamine 0.4%
Anestheric/Analgesic
Skin Protectant
For external use only. Avoid contact with the eyes
Do not use
Ask a doctor before use
Stop use and ask a doctor if condition worsens or does not improve within 7 days
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Aloe Badbadensis Leaf juice (Aloe Vera), Avena Sativa (Oat) Kernal colloidal, cetyl stearyl alcohol, ceteareth-6, ceteareth-25, diazolidinyl urea, fragrance, menthol, methyl paraben, paraffinum liquidum, propylene glycol, propyl paraben, purified water, stearyl alcohol
1-866-595-5598
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1798481 | pramoxine HCl 1 % / zinc oxide 0.4 % / calamine 0.4 % Topical Cream | PSN | 9 |
| 1798481 | calamine 4 MG/ML / pramoxine hydrochloride 10 MG/ML / zinc oxide 4 MG/ML Topical Cream | SCD | 9 |
| 1798481 | calamine 0.4 % / pramoxine HCl 1 % / zinc oxide 0.4 % Topical Cream | SY | 9 |
| 1798481 | Calamine 4 MG/ML / Pramoxine hydrochloride 10 MG/ML / ZNO 4 MG/ML Topical Cream | SY | 9 |
| Class | Version | Type | Effective |
|---|---|---|---|
| ZINC CATION Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f47a510b-6679-4664-b2d6-47b5c4afe7cc | Product name | 4 | 20260217 |
| 030ce964-9b2d-45aa-b5d3-f78ce03ef61c | Product name | 2 | 20250515 |
| 0306390c-dd77-4363-afe0-63c58088b2a1 | Product name | 1 | 20220120 |
| 503ea967-4b9c-48cf-9e87-c7975295849d | Product name | 2 | 20220120 |
| 190f2a5b-bbc8-65c7-fcb0-97891307b917 | Product name | 1 | 20140508 |
| 58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8 | Product name | 1 | 20140508 |
| a7051cba-790b-a699-81f8-dbbbdbd9b5ac | Product name | 1 | 20140508 |
| da108d9e-edc8-17a3-8c28-3251c6a8accc | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 54859-202-04 | 2020-12-23 | C162847 | 48780-1 | 9d75b9cf-e9ea-f424-e053-dadaa90a57ce | Dermagesic 202 |
| 54859-202-04 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-e9ea-f424-e053-dadaa90a57ce | Dermagesic 202 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54859-202-04 | Dermagesic | 113 g in 1 JAR | CREAM | 113 | 9 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 54859-202 | 54859-202-04 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALOE | V5VD430YW9 | IACT |
| AVENA SATIVA WHOLE | 5P8D0Z74RG | IACT |
| CETOSTEARYL ALCOHOL | 2DMT128M1S | IACT |
| CETEARETH-6 | 2RJS3559D3 | IACT |
| CETEARETH-25 | 8FA93U5T67 | IACT |
| DIAZOLIDINYL UREA | H5RIZ3MPW4 | IACT |
| MENTHOL | L7T10EIP3A | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| STEARYL ALCOHOL | 2KR89I4H1Y | IACT |
| PRAMOXINE HYDROCHLORIDE | 88AYB867L5 | ACTIB |
| ZINC OXIDE | SOI2LOH54Z | ACTIM |
| FERRIC OXIDE RED | 1K09F3G675 | ACTIB |
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 |
|---|---|---|---|---|---|---|
| Dermagesic | PRAMOXINE HCL, ZINC OXIDE, CALAMINE | Llorens Pharmaceutical International Division | bbff6b53-29da-45c1-8ccd-3e9df7f250e0 | 2025-12-31 | Warnings | 54859-202-04 54859-202 54859020204 47467902-6ca7-2b20-e063-6394a90aeff1 bbff6b53-29da-45c1-8ccd-3e9df7f250e0 |
Adverse event summaries are temporarily unavailable. Other product information remains available.