NDC 72895-081 Banish My Pain

Camphor

NDC Product Code 72895-081

NDC Product Information

Banish My Pain with NDC 72895-081 is a a human over the counter drug product labeled by Laiden Montana Emu Products. The generic name of Banish My Pain is camphor. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Laiden Montana Emu Products

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 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.

Banish My Pain Active Ingredient(s)

What 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) 2.576 g/60mL

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.

  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • EMU OIL (UNII: 344821WD61)
  • MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
  • GRAPEFRUIT SEED OIL (UNII: 598D944HOL)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • CAJUPUT OIL (UNII: J3TO6BUQ37)

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.

Product Labeler Information

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

Labeler Name: Laiden Montana Emu Products
Labeler Code: 72895
FDA Application Number: part348 What 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. 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: 05-06-2019 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: 12-31-2020 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.

Banish My Pain Product Label Images

Banish My Pain 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

Camphor 4.6%

Purpose

Topical analgesic

Uses

  • For the temporary relief of minor aches and pains of muscles and joints associated with:simple backachearthritisstrainsbruisessprains

Warnings

For external use only.

Do Not Use

  • On wounds or damaged skinwith a heating pad

When Using This Product

  • Avoid contact with eyes and mucous membranesdo not bandage tightly

Stop Use And Ask A Doctor If

  • Condition worsenssymptoms persist for more than 7 dayssymptoms 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

Directions

  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.massage into area until thoroughly absorbedChildren under 2 years of age: consult a doctor.

Other Information

  • Best stored at room temperature or cooler.

Inactive Ingredients

Helianthus Annuus (Sunflower) Seed Oil, Emu Oil, Beeswax, Butyrospermum Parkii (Shea) Butter, Arnica Montana Flower, Calendula Officinalis (Calendula) Flower, Melissa Officinalis (Lemon Balm) Leaf, Chamomilla Recutita (Chamomile) Flower, Tocopherol, Melaleuca Leucadendron Cajaputi (Cajeput) Oil, Lavandula Angustifolia (Lavender) Oil, Eucalyptus Globulus (Eucalyptus) Leaf Oil, Chamomilla Recutita (Chamomile) Oil, Citrus Grandis (Grapefruit) Seed Extract.

* Please review the disclaimer below.

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