NDC 72883-019 Coldsore Bomb

Zinc Oxide

NDC Product Code 72883-019

NDC Product Information

Coldsore Bomb with NDC 72883-019 is a a human over the counter drug product labeled by Envisionate Psj Llc. The generic name of Coldsore Bomb is zinc oxide. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Envisionate Psj Llc

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.


Coldsore Bomb 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 2.5 mg/g

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)
  • COCOA BUTTER (UNII: 512OYT1CRR)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • GRAPE SEED OIL (UNII: 930MLC8XGG)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • CROTON LECHLERI RESIN (UNII: GGG6W25C63)

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: Envisionate Psj Llc
Labeler Code: 72883
FDA Application Number: part348 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 03-25-2019 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.

Coldsore Bomb Product Label Images

Coldsore Bomb 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 Ingredients

Zinc Oxide (2.5mgs per 1g of product by input weight)

Purpose

External analgesic

Use

For temporary relief of pain and itching associated with fever blisters and cold sores

Warnings

For external use onlyStop use and ask a doctor if Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few daysWhen using this product Avoid contact with the eyes

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222).

Directions

  • Adults and children 2 years of age and older: Apply to the affected area not more than 3-4 times dailyChildren under 2 years of age: Consult a doctor

Other Information

Store at room temperature 68 to 77°F (20 to 25ºC).

Inactive Ingredients

Lanolin, Cocoa Butter, Coconut Oil, Grapeseed Oil, Peppermint Oil, Tea Tree Oil, Croton Lechleri Sap (Dragons Blood)

* Please review the disclaimer below.

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