FDA Label for Dermoscribe Diaper

View Indications, Usage & Precautions

Dermoscribe Diaper Product Label

The following document was submitted to the FDA by the labeler of this product Dermoscribe Pty Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients:



ZINC OXIDE 15%

CLIOQUINOL 1%


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.


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