NDC 72849-101 Little Bubs Diaper

Zinc Oxide

NDC Product Code 72849-101

NDC Product Information

Little Bubs Diaper with NDC 72849-101 is a a human over the counter drug product labeled by Little Bubs Company Pty Ltd. The generic name of Little Bubs Diaper is zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Little Bubs Company Pty Ltd

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Little Bubs Diaper Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ZINC OXIDE 15.25 g/100g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Little Bubs Company Pty Ltd
Labeler Code: 72849
FDA Application Number: part347 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 07-05-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Little Bubs Diaper Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

ZINC OXIDE 15.25%

Purpose

SKIN PROTECTANT

Uses

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

Warnings

  • FOR EXTERNAL USE ONLYWHEN USING THIS PRODUCT AVOID CONTACT WITH THE EYESSTOP USE AND ASK A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER 7 DAYSKEEP OUT OF REACH OF CHILDREN TO PREVENT ACCIDENTAL INGESTIONIF 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 INGESTIONIF SWALLOWED, SEEK MEDICAL HELP OR CALL PIOSON CONTROL CENTER IMMEDIATELY

Directions

  • REMOVE SEAL FROM CONTAINER PRIOR TO USECHANGE WET AND SOILED DIAPER IMMEDIATELYCLEANSE THE DIAPER AREA AND ALLOW TO DRYPUSH 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 REQUIREDAPPLY 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 BEDTIMERETURN 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

* Please review the disclaimer below.

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