Active Ingredients
Sulfur 3%, Salicylic Acid 3%, Hydrocortisone 1%
Dermoscribe Seborrheic Dermatitis Cream
FDA Label NDC 69683-202
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dermoscribe Pty Ltd for the product Dermoscribe Seborrheic Dermatitis (NDC 69683-202). 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, use, warnings, otc - keep out of reach of children, directions, inactive ingredients, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
TREATMENT OF SEBORRHEIC DERMATITIS.
Use
Dermoscribe's Seborrheic Dermatitis Cream is a topical treatment for relief of the symptoms and signs of Seborrheic Dermatitis.
Warnings
FOR EXTERNAL USE ONLY. Avoid contact with mouth, eyes and anal skin.
Do not swallow. Seek medical advice before using if pregnant or breastfeeding. If irritation
develops, stop using and seek medical advice. May not be as effective after expiry date.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
Directions
For use only by persons over 12 years old. Apply in a thin layer over the affected area once or twice daily as required.
Use only in accordance with the directions on the label and within the packaging. Refer to enclosed leaflet for detailed directions.
Inactive Ingredients
AQUEOUS CREAM
Other Safety Information
STORE AT ROOM TEMPERATURE
* Please review the disclaimer below.
