FDA.reportPublic FDA data

DERMOSCRIBE - DIAPER OINTMENT (69683-102)

Manufacturer
DERMOSCRIBE PTY LTD
Effective date
2022-12-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:52:34

Label at a glance#

ProductDERMOSCRIBE DIAPER
Active ingredientCLIOQUINOL, ZINC OXIDE
Label structure9 sections

Indications and uses

A SAFE, EFFECTIVE TREATMENT FOR THE SIGNS AND SYMPTOMS OF DIAPER RASH. REDUCES INFLAMMATION AND HELPS PREVENT BACTERIAL INFECTIONS.

Dosage and administration

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

ZINC OXIDE 15%

CLIOQUINOL 1%

PURPOSE

OTC - PURPOSE SECTION

ANTIFUNGAL

ANTIBACTERIAL

USES

INDICATIONS & USAGE SECTION

A SAFE, EFFECTIVE TREATMENT FOR THE SIGNS AND SYMPTOMS OF DIAPER RASH.

REDUCES INFLAMMATION AND HELPS PREVENT BACTERIAL INFECTIONS.

WARNINGS

WARNINGS SECTION

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 SECTION

KEEP OUT OF REACH OF CHILDREN.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2117976clioquinol 1 % / zinc oxide 15 % Topical OintmentPSN3
2117976clioquinol 0.01 MG/MG / zinc oxide 0.15 MG/MG Topical OintmentSCD3
2117976Clioquinol 0.01 MG/MG / ZNO 0.15 MG/MG Topical OintmentSY3
2117976clioquinol 1 % / zinc oxide 15 % Topical OintmentSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CLIOQUINOL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69683-102-112024-01-30C16284748780-11030e365-44dd-111a-e063-dadaa90a10e2DERMOSCRIBE - DIAPER OINTMENT (69683-102)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69683-102-11DERMOSCRIBE DIAPER100 g in 1 JAROINTMENT1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69683-102DERMOSCRIBE DIAPER (CLIOQUINOL, ZINC OXIDE) OINTMENT [DERMOSCRIBE PTY LTD]3Legacy NDC, 1 package rows20221223_2c448de2-a149-4392-8f78-b5e2bac82aa9.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69683-10269683-102-11

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
OLIVE OIL6UYK2W1W1EIACT
BORIC ACIDR57ZHV85D4IACT
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
YELLOW WAX2ZA36H0S2VIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PARAFFINI9O0E3H2ZEIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LANOLIN7EV65EAW6HIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
CLIOQUINOL7BHQ856EJ5ACTIB
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f0713de4-6f3e-5f5b-e053-2a95a90a49de2c448de2-a149-4392-8f78-b5e2bac82aa92022-12-22WarningsExact identifier
spl id: f0713de4-6f3e-5f5b-e053-2a95a90a49de
spl set id: 2c448de2-a149-4392-8f78-b5e2bac82aa9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.