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Product NDC Code | 72849-101 | ||||
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Drug Name | Little bubs diaper |
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Type | Brand | ||||
Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
RxCUI drug identifier | 1793915 | ||||
Application Number | M016 | ||||
Labeler Name | LITTLE BUBS COMPANY PTY LTD | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT ZINC OXIDE 15.25%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.USES HELPS TREAT AND PREVENT DIAPER RASH PROTECTS CHAFED SKIN DUE TO DIAPER RASH AND HELPS SEAL OUT WETNESS
Purpose
Information about the drug product’s indications for use.PURPOSE SKIN PROTECTANT
Spl product data elements
Usually a list of ingredients in a drug product.LITTLE BUBS DIAPER ZINC OXIDE YELLOW WAX CYCLOMETHICONE 5 DISTEARDIMONIUM HECTORITE LANOLIN LAVENDER OIL MICROCRYSTALLINE WAX OLIVE OIL ALOE VERA LEAF CALENDULA OFFICINALIS FLOWER CHAMOMILE CERESIN PARAFFIN POLYSORBATE 60 PROPYLENE CARBONATE SORBITAN SESQUIOLEATE ZINC OXIDE ZINC CATION
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.01b LBL_Diaper Brush and Cream
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.KEEP OUT OF REACH OF CHILDREN TO PREVENT ACCIDENTAL INGESTION IF SWALLOWED, SEEK MEDICAL HELP OR CALL PIOSON CONTROL CENTER IMMEDIATELY
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.OTHER INFORMATION STORE AT ROOM TEMPERATURE 20C TO 27C (68F TO 80F) USE WITH INFANTS, CHILDREN AND ADULTS
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API