NDC 73417-758 Painonil

Eugenol, Camphor, Eucalyptus

NDC Product Code 73417-758

NDC CODE: 73417-758

Proprietary Name: Painonil 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: Eugenol, Camphor, Eucalyptus 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.

Product Characteristics

Color(s):
YELLOW (C48330)

NDC Code Structure

  • 73417 - Phytobiologic Pharmaceutics Llc

NDC 73417-758-52

Package Description: 1 TUBE in 1 CARTON > 25 g in 1 TUBE

NDC Product Information

Painonil with NDC 73417-758 is a a human over the counter drug product labeled by Phytobiologic Pharmaceutics Llc. The generic name of Painonil is eugenol, camphor, eucalyptus. The product's dosage form is ointment and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 2566044.

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.

Painonil 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.


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.

  • FENUGREEK SEED (UNII: 654825W09Z)
  • MUSTARD OIL (UNII: TYY1MA9BSY)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • RUBIA CORDIFOLIA ROOT (UNII: 4V873H15CG)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • TURMERIC (UNII: 856YO1Z64F)
  • ONION JUICE (UNII: 77539R6FGN)
  • GINGER (UNII: C5529G5JPQ)
  • ANISE OIL (UNII: 6Y89129C8H)

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: Phytobiologic Pharmaceutics Llc
Labeler Code: 73417
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: 08-12-2021 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: 12-31-2022 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 - NO 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.

Painonil 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

Painonil Active Ingredients

Active IngredientStrengthPurposeCamphor8%External analgesicEucalyptus oil5%External analgesicEugenol2%Analgesic & Anesthetic

Purpose

For rapid and sustained relief of pain.

Uses

  • For rapid and sustained relief of pain in joints, muscles, and tendons caused due to:Sprainssports injuriesfallsback & neck injuriesinflammationswellingexcessive use of joints

Warnings

  • For external use only.Avoid contact with eyes and mucous membranes.Use only as directed.Stop use and consult a doctor if: Skin rash or allergy occurs.If pregnant or breast-feeding, or symptoms persist, consult medical professional.Keep out of children's reach. If swallowed, get immediate medical help.

Directions

Apply a generous amount of the ointment (~1g) on the affected area 3 times daily and massage gently. For faster results*, apply mild heat at the effected area with a heat lamp or heat pad after each application.Do not use for children under 5 years of age.
* Individual results may vary.

When Using This Product

  • Do not apply excessive external heat

Stop Use Section

  • Stop use of this product and consult a doctor If:Skin rash occurs

If Pregnant Or Breat Feeding

If pregnant or breast-feeding, or symptoms persist, consult medical professional before use

Keep Out Of Reach Of Children

Keep out of children's reach.
If swallowed, get immediate medical help.

Other Information

  • Store in room temperature 40
  • 0F to 86
  • 0F (4
  • 0C to 30
  • 0C)
  • Bioactive formula has a natural color that can stain cloths

Inactive Ingredients

Inactive ingredients

Aloe vera extract, Anise seed extract, Azadirachta indica extract, Beeswax, Curcuma longa root extract, Fenugreek seed extract, Fragrance, Ginger extract, Mustard oil, Onion extract, Peppermint oil, Petroleum jelly, Rubia cordifolia extract.

Recent Major Changes

  • Active Ingredients (Camphor -- 8% External analgesic, Eucalyptus Oil -- 5% External analgesic, Eugenol -- 2% Analgesic & Anesthetic)Inactive ingredients
  • Aloe vera extract, Anise seed extract, Azadirachta indica extract, Beeswax, Curcuma longa root extract, Fenugreek seed extract, Fragrance, Ginger extract, Mustard oil, Onion extract, Peppermint oil, Petroleum jelly, Rubia cordifolia extract.

* Please review the disclaimer below.