NDC 68345-818 Repara

NDC Product Code 68345-818

NDC 68345-818-25

Package Description: 144 PACKAGE in 1 CARTON > 5 g in 1 PACKAGE

NDC 68345-818-26

Package Description: 114 g in 1 TUBE

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

NDC Product Information

Repara with NDC 68345-818 is a product labeled by Pss World Medical, Inc.. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 853167.

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)
  • HYDROXYETHYLETHYLENEDIAMINETRIACETIC ACID (UNII: R79J91U341)
  • LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • OXYQUINOLINE (UNII: 5UTX5635HP)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BORATE (UNII: 91MBZ8H3QO)
  • SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)

Product Labeler Information

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

Labeler Name: Pss World Medical, Inc.
Labeler Code: 68345
Start Marketing Date: 08-06-2014 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: 12-31-2017 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.

Repara 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                            PurposeLanolin USP 50% .................. Skin Protectant

Otc - Purpose

  • Repara Advanced SkincareSkin Protectant w/ LanolinMulti-PurposeContains 50% Lanolin USPSkin Barrier for Incontinence Diaper RashProtects chafed or ulcer prone skinLight Scent

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

  • DirectionsGently cleanse and dry area.Apply liberally to affected area as needed.

Warnings

  • WarningsFor external use onlyWhen using this productdo not get into eyes.Do not apply to deep or puncture wounds.Stop use and ask a doctor ifcondition worsenssymptoms last more than 7 days or clear up and occur again within a few days.

Indications & Usage

  • Indications: Intended to help protect chafed skin or minor skin irritations, as well as to prevent diaper dermatitis.Precautions: FOR EXTERNAL USE ONLY. Discontinue use should irritation occur. Do not use on deep puncture wounds, animal bites, and serious burns.Frequency: Daily.UsesHelps prevent diaper dermatitis.Protects chafed skin or minor skin irritations due to incontinence and helps seal out wetness.

Inactive Ingredient

Inactive Ingredientsbeeswax (yellow wax), fragrance, HEEDTA, lanolin alcohol, mineral oil, oxyquinolone, petrolatum, purified water, sodium borate, sorbitan sesquioleate.

Other Safety Information

Manufactured for PSS World Medical, Inc.4345 Southpoint Blvd., Jacksonville, FL 32216Comments or Questions? 800-777-4908Made in the USAOther InformationStore at 20oC - 25oC (68oF - 77oF).

* Please review the disclaimer below.