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  5. Label Information: Little Bubs Diaper

FDA Label for Little Bubs Diaper

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Little Bubs Diaper Product Label

The following document was submitted to the FDA by the labeler of this product Little Bubs Company Pty Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

Otc - 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


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