FDA.reportPublic FDA data

LITTLE BUBS - DIAPER BRUSH AND CREAM (72849-101)

Manufacturer
LITTLE BUBS COMPANY PTY LTD
Effective date
2024-01-09
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:07:45

Label at a glance#

ProductLITTLE BUBS DIAPER
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

HELPS TREAT AND PREVENT DIAPER RASH PROTECTS CHAFED SKIN DUE TO DIAPER RASH AND HELPS SEAL OUT WETNESS

Dosage and administration

REMOVE SEAL FROM CONTAINER PRIOR TO USE CHANGE WET AND SOILED DIAPER IMMEDIATELY CLEANSE THE DIAPER AREA AND ALLOW TO DRY PUSH BUTTON TO ACCESS CREAM. SWEEP THE APPLICATOR BRUSH MOVING THE BRISTLES BACK AND FORTH IN A SEMI-CIRCLE LOADING CREAM ONTO YOUR DIAPER BRUSH AS REQUIRED APPLY CREAM LIBERALLY AND AS OFTEN AS NECESSARY WITH EACH DIAPER CHANGE AND ESPECIALLY WHEN EXPOSED TO WET DIAPERS FOR A PROLONGED PERIOD ...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

ZINC OXIDE 15.25%

PURPOSE

OTC - PURPOSE SECTION

SKIN PROTECTANT

USES

INDICATIONS & USAGE SECTION

  • HELPS TREAT AND PREVENT DIAPER RASH
  • PROTECTS CHAFED SKIN DUE TO DIAPER RASH AND HELPS SEAL OUT WETNESS

WARNINGS

WARNINGS SECTION

  • FOR EXTERNAL USE ONLY
  • WHEN USING THIS PRODUCT AVOID CONTACT WITH THE EYES
  • STOP USE AND ASK A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER 7 DAYS
  • KEEP OUT OF REACH OF CHILDREN TO PREVENT ACCIDENTAL INGESTION
  • IF SWALLOWED, SEEK MEDICAL HELP OR CALL PIOSON CONTROL CENTER IMMEDIATELY

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • KEEP OUT OF REACH OF CHILDREN TO PREVENT ACCIDENTAL INGESTION
  • IF SWALLOWED, SEEK MEDICAL HELP OR CALL PIOSON CONTROL CENTER IMMEDIATELY

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • REMOVE SEAL FROM CONTAINER PRIOR TO USE
  • CHANGE WET AND SOILED DIAPER IMMEDIATELY
  • CLEANSE THE DIAPER AREA AND ALLOW TO DRY
  • PUSH BUTTON TO ACCESS CREAM. SWEEP THE APPLICATOR BRUSH MOVING THE BRISTLES BACK AND FORTH IN A SEMI-CIRCLE LOADING CREAM ONTO YOUR DIAPER BRUSH AS REQUIRED
  • APPLY CREAM LIBERALLY AND AS OFTEN AS NECESSARY WITH EACH DIAPER CHANGE AND ESPECIALLY WHEN EXPOSED TO WET DIAPERS FOR A PROLONGED PERIOD OF TIME, SUCH AS BEDTIME
  • RETURN YOUR DIAPER BRUSH TO ITS CENTER CAVITY AND CLOSE THE LID. ONCE BABY HAS BEEN SAFELY SET DOWN, USE A BABY WIPE OR TISSUE TO SPOT CLEAN YOUR DIAPER BRUSH IF REQUIRED.

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • STORE AT ROOM TEMPERATURE 20C TO 27C (68F TO 80F)
  • USE WITH INFANTS, CHILDREN AND ADULTS

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

CERA ALBA (BEESWAX), CYCLOPENTASILOXANE, DISTEARDIMONIUM HECTORITE, LANOLIN, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, MICROCRYSTALLINE WAX, OLEA EUROPAEA (OLIVE) OIL, ORGANIC ALOE BARBADENSIS (ALOE VERA) LEAF EXTRACT, ORGANIC CALENDULA OFFICINALIS (CALENDULA) FLOWER EXTRACT, ORGANIC MATRICARIA RECUTITA (CHAMOMILE) FLOWER EXTRACT, OZOKERITE, PARAFFIN WAX, POLYSORBATE 60, PROPYLENE CARBONATE, SORBITAN SESQUIOLEATE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Diaper Brush and Cream01b LBL_Diaper Brush and Cream

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1793915zinc oxide 15.25 % Topical CreamPSN6
1793915zinc oxide 153 MG/ML Topical CreamSCD6
1793915zinc oxide 15.25 % Topical CreamSY6
1793915ZNO 153 MG/ML Topical CreamSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
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
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72849-101-11LITTLE BUBS DIAPER350 g in 1 JARCREAM3506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72849-101LITTLE BUBS DIAPER (ZINC OXIDE) CREAM [LITTLE BUBS COMPANY PTY LTD]6Legacy NDC, 1 package rows20240124_9a720d23-bacd-4955-a1ca-d05ad013dd3b.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72849-10172849-101-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
YELLOW WAX2ZA36H0S2VIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
LANOLIN7EV65EAW6HIACT
LAVENDER OILZBP1YXW0H8IACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
OLIVE OIL6UYK2W1W1EIACT
ALOE VERA LEAFZY81Z83H0XIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CHAMOMILEFGL3685T2XIACT
CERESINQ1LS2UJO3AIACT
PARAFFINI9O0E3H2ZEIACT
POLYSORBATE 60CAL22UVI4MIACT
PROPYLENE CARBONATE8D08K3S51EIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
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
0fa1311a-4d01-ca05-e063-6394a90a75789a720d23-bacd-4955-a1ca-d05ad013dd3b2024-01-09WarningsExact identifier
spl id: 0fa1311a-4d01-ca05-e063-6394a90a7578
spl set id: 9a720d23-bacd-4955-a1ca-d05ad013dd3b

Reported adverse events (FAERS/openFDA)#

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