Active Ingredients:
ZINC OXIDE 15%
CLIOQUINOL 1%
Dermoscribe Diaper
FDA Label NDC 69683-102
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 Diaper (NDC 69683-102). 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, 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
ANTIFUNGAL
ANTIBACTERIAL
Uses
A SAFE, EFFECTIVE TREATMENT FOR THE SIGNS AND SYMPTOMS OF DIAPER RASH.
REDUCES INFLAMMATION AND HELPS PREVENT BACTERIAL INFECTIONS.
Warnings
WARNINGS
FOR EXTERNAL USE ONLY
IF BABY'S CONDITION FAILS TO IMPROVE, SEE YOUR DOCTOR.
DO NOT USE IF BABY IS ALLERGIC TO ANY OF THE INGREDIENTS.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
Directions:
WASH HANDS WITH SOAP AND WATER BEFORE AND AFTER USE. USING FINGERS, GENTLY APPLY OINTMENT OVER AFFECTED AREA. FOLLOWING AN INITIAL FLARE-UP, APPLY OINTMENT AFTER EVERY DIAPER CHANGE. ONCE THE RASH HAS SETTLED, APPLY TWO OR THREE TIMES DAILY, AS REQUIRED. ASK YOUR HEALTHCARE PROFESSIONAL IF YOU ARE UNSURE OF THE CORRECT DOSAGE FOR YOUR BABY.
Inactive Ingredients
OLIVE OIL 17.5%, BORIC ACID 0.25%, MINERAL OIL, PETROLATUM, BEESWAX, GLYCERYL STEARATE, PARAFFIN WAX, VITAMIN E, LANOLIN, POTASSIUM SORBATE, SODIUM BENZOATE.
Other Safety Information
STORE AT ROOM TEMPERATURE IN A DRY PLACE, AWAY FROM DIRECT SUNLIGHT AND OUT OF REACH OF CHILDREN. MAY NOT BE AS EFFECTIVE AFTER EXPIRY DATE.
* Please review the disclaimer below.
