NDC 70000-0469 Zinc Oxide 40%

Diaper Rash Skin Protectent

NDC Product Code 70000-0469

NDC Code: 70000-0469

Proprietary Name: Zinc Oxide 40% Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Diaper Rash Skin Protectent Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 70000 - Cardinal Health
    • 70000-0469 - Zinc Oxide 40%

NDC 70000-0469-1

Package Description: 72 BOX in 1 CASE > 1 TUBE in 1 BOX > 113 g in 1 TUBE

NDC Product Information

Zinc Oxide 40% with NDC 70000-0469 is a a human over the counter drug product labeled by Cardinal Health. The generic name of Zinc Oxide 40% is diaper rash skin protectent. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Cardinal Health

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >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 Additional informationCallout TooltipWhat 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.


Zinc Oxide 40% Active Ingredient(s)

Additional informationCallout TooltipWhat 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 4 g/100g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • LANOLIN (UNII: 7EV65EAW6H)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • COD LIVER OIL (UNII: BBL281NWFG)
  • TALC (UNII: 7SEV7J4R1U)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Cardinal Health
Labeler Code: 70000
FDA Application Number: part347 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 01-30-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Zinc Oxide 40% Product Label Images

Zinc Oxide 40% 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 40%

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 only

When Using This Product

Do not get into eyes

Stop Use And Ask A Doctor If

  • Condition worsens.symptoms last more than 7 days or clear up and occur again within a few days

Otc - Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • Change wet and soiled diapers promptlycleanse the diaper areaallow to dryapply paste liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other Information

  • Store at 20°C to 25°C (68°F to 77°F)may stain clothing

Inactive Ingredients

Beeswax, cod liver oil, fragrance, glycerine, lanoline, sorbitan soquioleate, talcum, tocopheryl acetate, white soft paraffin

* Please review the disclaimer below.

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