Label: LITTLE BUBS DIAPER- zinc oxide cream

  • NDC Code(s): 72849-101-11
  • Packager: LITTLE BUBS COMPANY PTY LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 9, 2024

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  • ACTIVE INGREDIENT

    ZINC OXIDE 15.25%

  • PURPOSE

    SKIN PROTECTANT

  • USES

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

    • 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
  • KEEP OUT OF REACH OF CHILDREN

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

    • 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

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

    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

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Diaper Brush and Cream

  • INGREDIENTS AND APPEARANCE
    LITTLE BUBS DIAPER 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72849-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION15.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    LANOLIN (UNII: 7EV65EAW6H)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CERESIN (UNII: Q1LS2UJO3A)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72849-101-11350 g in 1 JAR; Type 0: Not a Combination Product07/05/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01607/05/2019
    Labeler - LITTLE BUBS COMPANY PTY LTD (890711880)
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