NDC 81450-005 Ziva Baby Wipes

Zinc Oxide

NDC Product Code 81450-005

NDC Product Information

Ziva Baby Wipes with NDC 81450-005 is a a human over the counter drug product labeled by Ziva Wetwipes Fzco. The generic name of Ziva Baby Wipes is zinc oxide. The product's dosage form is cloth and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 2588075.

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.

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.

Ziva Baby Wipes 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.


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.

  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
  • CHAMOMILE (UNII: FGL3685T2X)
  • SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)

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: Ziva Wetwipes Fzco
Labeler Code: 81450
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: 12-24-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Ziva Baby Wipes Product Label Images

Ziva Baby Wipes 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 0.1%

Direction For Use

Peel back the front label or open  the flip top slowly. Pull wipes as needed. Gently cleanse your baby's skin using one or more wipes. Reseal pouch by firmly running thumb over label to close the flip top to prevent moisture loss.

Precautions:

For external use only. Do not apply to irritated or damaged skin. In case of gluteal erythema (redness of skin), contact your doctor or pharmacist. Keep in a cool place away from direct sunlight. Prevent contact with eyes. In case of irritation wash away with water immediately.

Ingredients:

Aqua, Zinc Oxide, Pentylene Glycol and Glyceryl Caprylate / Caprate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate (Vitamin E), Propylene Glycol, Sodium cocoamphoacetate, Disodium cocoamphodiacetate,  Cocamidoproply Betaine, PEG 40 Hydrogenated Castor Oil, Chamomile Extract, PEG-120 Methyl Glucose Dioleate,  Disodium EDTA, Citric Acid.

* Please review the disclaimer below.