DERMOSCRIBE DIAPER- clioquinol, zinc oxide ointment

DERMOSCRIBE DIAPER by

Drug Labeling and Warnings

DERMOSCRIBE DIAPER by is a Otc medication manufactured, distributed, or labeled by DERMOSCRIBE PTY LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMOSCRIBE DIAPER 
clioquinol, zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69683-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLIOQUINOL (UNII: 7BHQ856EJ5) (CLIOQUINOL - UNII:7BHQ856EJ5)	CLIOQUINOL	1 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OLIVE OIL (UNII: 6UYK2W1W1E)
BORIC ACID (UNII: R57ZHV85D4)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
YELLOW WAX (UNII: 2ZA36H0S2V)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PARAFFIN (UNII: I9O0E3H2ZE)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LANOLIN (UNII: 7EV65EAW6H)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69683-102-11	100 g in 1 JAR; Type 0: Not a Combination Product	03/23/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/23/2015

Labeler - DERMOSCRIBE PTY LTD (742164734)