Dermesse Pad Treatment 2.0
FDA Label NDC 68723-401

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Axia Medical Solutions, Llc for the product Dermesse Pad Treatment 2.0 (NDC 68723-401). 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 active ingredients, purpose, uses:, warninigs:, ask a doctor or pharmacist before use if you are:, keep out of reach of children, directions:, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

0.5% Salicylic Acid

2% Salicylic Acid

Purpose

Acne Treatment

Uses:

For the treatment of acne

Warninigs:

For external use only

Combustibles. Keep away from fire or flames.

Ask A Doctor Or Pharmacist Before Use If You Are:

using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs only one medication should be used unless directed by a doctor.

Keep Out Of Reach Of Children

If swallowed get medical help or contact a Poison Control center right away.

Directions:

  • Cleanse the skin thoroughly before applying medication
  • Cover the entire affected area with a thin layer one to three times daily.
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or directed by a doctor.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Other Information:

Store at controlled room temperature 15-300C (59-860F), away from diret sunlight.

Inactive Ingredients:

Ammonium Hydroxide, Edetate Disodium, Ethyl Alcohol SD40, Glycolic Acid, Propylene Glycol, Purified Water, Nonoxynol 9.

* Please review the disclaimer below.