Otc - Active Ingredient
Active Ingredients:
Salicylic Acid 2%
Nixoderm Unguento
FDA Label NDC 70344-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Laboratorios Incobra S.a. for the product Nixoderm Unguento (NDC 70344-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, dosage & administration, warnings, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Acne Treatment
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, contact physician or poison control center immediately.
Indications & Usage
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
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
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
Other Ingredients: beeswax, BHT, benzoic acid, petrolatum, polysorbate 80, sulfur, zinc oxide.
Package Label.Principal Display Panel
Image Description (Label)
* Please review the disclaimer below.
