DERMOSCRIBE DIAPER- clioquinol, zinc oxide ointment 
DERMOSCRIBE PTY LTD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DERMOSCRIBE - DIAPER OINTMENT (69683-102)

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.

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.

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.

Diaper Ointment Clear Label REVISED 40mm x 175mm PRINT READY FINAL 22012019-01

DERMOSCRIBE DIAPER 
clioquinol, zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69683-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLIOQUINOL (UNII: 7BHQ856EJ5) (CLIOQUINOL - UNII:7BHQ856EJ5) CLIOQUINOL1 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69683-102-11100 g in 1 JAR; Type 0: Not a Combination Product03/23/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/23/2015
Labeler - DERMOSCRIBE PTY LTD (742164734)

Revised: 12/2022
Document Id: f0713de4-6f3e-5f5b-e053-2a95a90a49de
Set id: 2c448de2-a149-4392-8f78-b5e2bac82aa9
Version: 3
Effective Time: 20221222
 
DERMOSCRIBE PTY LTD