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

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 - INACTIVATED, the listing data was inactivated by the FDA. 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.

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.