NDC 68786-226 Zinc Oxide

NDC Product Code 68786-226

NDC 68786-226-01

Package Description: 6 BOX in 1 CASE > 144 PACKET in 1 BOX > 5 g in 1 PACKET

NDC 68786-226-02

Package Description: 6 BOX in 1 CASE > 36 PACKET in 1 BOX > 15 g in 1 PACKET

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Zinc Oxide with NDC 68786-226 is a product labeled by Sion Biotext Medical Ltd. The generic name of Zinc Oxide is . The product's dosage form is and is administered via form.

Labeler Name: Sion Biotext Medical Ltd

Dosage Form: -

Product Type: 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.

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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • DIAZOLIDINYLUREA (UNII: H5RIZ3MPW4)
  • LANOLIN (UNII: 7EV65EAW6H)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • SODIUM BORATE (UNII: 91MBZ8H3QO)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
  • CORN OIL (UNII: 8470G57WFM)
  • WATER (UNII: 059QF0KO0R)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Labeler Information

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

Labeler Name: Sion Biotext Medical Ltd
Labeler Code: 68786
Start Marketing Date: 02-01-2010 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: 12-31-2018 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: I 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.

Zinc Oxide Product Label Images

Zinc Oxide 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

Otc - Active Ingredient

Active Ingredient               PurposeZinc Oxide (1.8% w/w)      Skin Protectant

Uses:

  • Helps treat and prevent diaper rashTemporarily protects minor cuts scrapes and burnsdries the oozing and weeping ofpoison ivypoison oakpoison sumac

Warnings:

For External Use Only.

When Using This Product:

Do not get in eyes.

Stop Use And Ask A Doctor If:

  • Condition worsenssymptoms last more than 7 days or clear up and occur again in a few days, consult a physician

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

  • For skin protectant:Apply liberally as needed           For diaper Rash:change wet and soiled diapers promptlyallow to dryapply ointment liberally with each diaper change

Other Information:

  • Store at room temperature avoid excessive heat contains color additives including FDC yellow # 5

* Please review the disclaimer below.