OTC - ACTIVE INGREDIENT SECTION
Active Ingredients:
Salicylic Acid 2%
Nixoderm Unguento
- Manufacturer
- Laboratorios Incobra S.A.
- Effective date
- 2016-02-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:44:56
Label at a glance#
ProductNixoderm Unguento
Active ingredientSALICYLIC ACID
Label structure8 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
Acne Treatment
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, contact physician or poison control center immediately.
INDICATIONS & USAGE SECTION
For Skin Acne treatment
For relief, irritation, redness and of Acne
Indications:
*For the treatment of Acne. Clears up acne pimples and blemishes, and allows skin to heal. Helpsprevent new pimples and blemishes from forming.
DOSAGE & ADMINISTRATION SECTION
Directions:
*Clean the skin thoroughly before applying this product.
*Cover the entire affected area with a thing layer one to three times daily, then gradually increase to two or three time daily if needed or as directed by a doctor
*If bothersome dryness or peeling occurs, reduce application to once a day or every other day
WARNINGS SECTION
Warnings:
*For external use only.
*Avoid contact with eyes. If contact occurs, rinse thoroughly with water
When using this product
*Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use only topical acne medication at a time
*Do not use without consulting a doctor if the condition appears over a large portion of the body.
Store at room temperature.
INACTIVE INGREDIENT SECTION
Other Ingredients: beeswax, BHT, benzoic acid, petrolatum, polysorbate 80, sulfur, zinc oxide.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70344-001-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e260-f424-e053-dadaa90a57ce | 528e48cb-9f36-4717-896c-0bae3d997e6e |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70344-001-01 | Nixoderm Unguento | 20 g in 1 PACKAGE | OINTMENT | 20 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Nixoderm Unguento
- salicylic acid
- YELLOW WAX
- BUTYLATED HYDROXYTOLUENE
- BENZOIC ACID
- PETROLATUM
- POLYSORBATE 80
- SULFUR
- ZINC OXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70344-001 | 70344-001-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SALICYLIC ACID | O414PZ4LPZ | ACTIB |
| YELLOW WAX | 2ZA36H0S2V | IACT |
| BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | IACT |
| BENZOIC ACID | 8SKN0B0MIM | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| SULFUR | 70FD1KFU70 | IACT |
| ZINC OXIDE | SOI2LOH54Z | IACT |
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 |
|---|---|---|---|---|---|---|
| d03a2040-5af8-4fc0-bbbe-825345c0782e | 528e48cb-9f36-4717-896c-0bae3d997e6e | 2016-02-10 | Warnings | d03a2040-5af8-4fc0-bbbe-825345c0782e 528e48cb-9f36-4717-896c-0bae3d997e6e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.