NDC 72979-001 Painkillernaturalointment

Menthol, Camphor Ointment

NDC Product Code 72979-001

NDC Code: 72979-001

Proprietary Name: Painkillernaturalointment Additional informationCallout TooltipWhat 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: Menthol, Camphor Ointment Additional informationCallout TooltipWhat 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.


Code Structure
  • 72979 - Regenesis Pharmaceutical Inc.
    • 72979-001 - Painkillernaturalointment

NDC 72979-001-15

Package Description: 15 g in 1 CANISTER

NDC Product Information

Painkillernaturalointment with NDC 72979-001 is a a human over the counter drug product labeled by Regenesis Pharmaceutical Inc.. The generic name of Painkillernaturalointment is menthol, camphor ointment. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Regenesis Pharmaceutical Inc.

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.


Painkillernaturalointment 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.

  • CAMPHOR (NATURAL) .1 g/g
  • MENTHOL .1 g/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.

  • CINNAMON (UNII: 5S29HWU6QB)
  • MYRRH OIL (UNII: H74221J5J4)
  • CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
  • CHINESE CINNAMON LEAF OIL (UNII: 4U4V2F2E4Y)
  • ORANGE OIL (UNII: AKN3KSD11B)
  • YELLOW WAX (UNII: 2ZA36H0S2V)

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: Regenesis Pharmaceutical Inc.
Labeler Code: 72979
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: 03-20-2019 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.

Painkillernaturalointment Product Label Images

Painkillernaturalointment 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

Menthol 10%Camphor 10%

Otc - Purpose

Topical analgesic​

Inactive Ingredient

Hemp oilCassia leafOrange peel oilBeeswaxCinnamonMyrrh oil

Dosage & Administration

Apply liberally as needed.

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.

Warnings

  • For external use only.avoid contact with eyes and mucous membranesStop use and ask a doctor ifExcessive skin irritation condition worsenssymptoms persist for more than 7 days or clear up and occur again within a few daysIf pregnant or breast-feeding ask a health professional before use

* Please review the disclaimer below.

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