NDC 66513-220 Bronco Rub

Camphor Eucalyptus Menthol

NDC Product Code 66513-220

NDC 66513-220-14

Package Description: 39 g in 1 JAR

NDC Product Information

Bronco Rub with NDC 66513-220 is a a human over the counter drug product labeled by Distribuidora De Alimentos Naturales Y Nutricionales, S.a. De C.v. The generic name of Bronco Rub is camphor eucalyptus menthol. 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: 727137.

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.

Bronco Rub 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.

  • PETROLATUM (UNII: 4T6H12BN9U)
  • TURPENTINE OIL (UNII: C5H0QJ6V7F)

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: Distribuidora De Alimentos Naturales Y Nutricionales, S.a. De C.v
Labeler Code: 66513
FDA Application Number: part341 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 08-15-2014 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 - 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.

Bronco Rub Product Label Images

Bronco Rub 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

Camphor 4.8%Eucalyptus 1.2%Menthol 2.6%

Purpose

Cough Suppressant/Topical AnlagesicCough SuppressantCough Suppressant/Topical Anlagesic

Uses

• on chest and throat, temporarily relieves cough due to common cold • temporarily relieves minor aches and pains of muscles and joints

Warnings

For external use only. Avoid contact with eyes.

Do Not Use

• by mouth or in nostrils • with tight bandages • on wounds or damaged skin

Ask A Doctor Before Use If You Have

• cough that occurs with too much phlegm (mucus) • persistent or chronic cough such as occurs with smoking, asthma or emphysema

When Using This Product Do Not

• heat • microwave • use near an open flame • add to hot water or any container where heating water. May cause splattering and result in burns.

Stop Use And Ask A Doctor If

• muscle aches and pains worsen, persist for more than 7 days or come back within a few days • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition

If Pregnant Or Breast Feeding

Ask a health professional before use.

Keep Out Of Reach Of Children

If swallowed get medical help or contact a Poison Control Center immediately.

Directions

See important warnings under "When using this product" section•adults and children 2 years and over rub a thick layer on chest and throat or rub on sore aching muscles •cover with a warm, dry cloth if desired • keep clothing loose about throat/chest to help vapors reach the nose/mouth • repeat up to three times per 24 hours or as directed by doctor • children under 2 years: do not use

Other Information

• store at room temperature

Inactive Ingredients

Petrolatum and Turpentine oil

* Please review the disclaimer below.