NDC 76420-701 St Covid-pod (saliva Collection Kit)

White Petrolatum, Isopropyl Alcohol

NDC Product Code 76420-701

NDC CODE: 76420-701

Proprietary Name: St Covid-pod (saliva Collection Kit) What 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: White Petrolatum, Isopropyl Alcohol What 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.

NDC Code Structure

  • 76420 - Asclemed Usa, Inc.
    • 76420-701 - St Covid-pod (saliva Collection Kit)

NDC 76420-701-10

Package Description: 1 KIT in 1 CARTON * 5 g in 1 PACKET (53329-068-16) * 5 mL in 1 POUCH

NDC Product Information

St Covid-pod (saliva Collection Kit) with NDC 76420-701 is a a human prescription drug product labeled by Asclemed Usa, Inc.. The generic name of St Covid-pod (saliva Collection Kit) is white petrolatum, isopropyl alcohol. The product's dosage form is kit and is administered via topical form.

Labeler Name: Asclemed Usa, Inc.

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Prescription 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.

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.

  • WATER (UNII: 059QF0KO0R)

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.
  • 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: Asclemed Usa, Inc.
Labeler Code: 76420
Marketing Category: UNAPPROVED DRUG OTHER - 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: 09-23-2020 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: 12-31-2021 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 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.

St Covid-pod (saliva Collection Kit) Product Label Images

St Covid-pod (saliva Collection Kit) 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

Isopropyl Alcohol 70% v/v

Purpose

Antiseptic

Skin Protectant

Uses

  • For first aid to decrease germs inminor cutsscrapesburnsFor preparation of the skin prior to injection

  • Temporarily protects minor: cuts, scrapes and burnstemporarily protects and helps relieve chapped or cracked skin and lipshelps protect from the drying effects of wind and cold weather

Warnings

For external use onlyFlammable - keep away from fire or flame

  • For external use only

Do Not Use

With electrocautery procedures

When Using This Product Do Not

  • Get into eyesapply over large areas of the bodyin case of deep or puncture wounds, animal bites or serious burns consult a doctor

Stop Use And Ask A Doctor If

  • Condition persists or gets worse or lasts for more than 72 hoursdo not use longer than 1 week unless directed by a doctor

  • Condition worsenssymptoms last for more than 7 days or clear up and occur again within a few days

Keep Out Of Reach Of Children.

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

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

Directions

  • Apply to skin as neededdiscard after single use

Apply as needed.

Other Information

Protect from freezing and avoid excessive heat

  • Store at controlled room temperature 68º-77ºF (20º-25ºC).Use only if packaging is intact.

Inactive Ingredient

Water

Active Ingredient (In Each Gram)

Petrolatum 100%

Do Not Use On

  • Deep or puncture woundsanimal bitesserious burns

When Using This Product

  • Avoid contact with eyes

* Please review the disclaimer below.