NDC 50804-078 Medicated Chest Rub

Camphor (synthetic), Eucalyptus Oil, And Menthol, Unspecified Form

NDC Product Code 50804-078

NDC 50804-078-01

Package Description: 100 g in 1 JAR

NDC Product Information

Medicated Chest Rub with NDC 50804-078 is a a human over the counter drug product labeled by Goodsense. The generic name of Medicated Chest Rub is camphor (synthetic), eucalyptus oil, and menthol, unspecified form. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Goodsense

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.

Medicated Chest 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.

  • CAMPHOR (SYNTHETIC) .048 g/g
  • EUCALYPTUS OIL .012 g/g
  • MENTHOL, UNSPECIFIED FORM .026 g/g

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.

  • CEDAR LEAF OIL (UNII: BJ169U4NLG)
  • NUTMEG OIL (UNII: Z1CLM48948)
  • TURPENTINE OIL (UNII: C5H0QJ6V7F)
  • THYMOL (UNII: 3J50XA376E)
  • WHITE PETROLATUM (UNII: B6E5W8RQJ4)

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: Goodsense
Labeler Code: 50804
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: 02-11-2021 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 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.

Medicated Chest Rub Product Label Images

Medicated Chest 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

Other

Drug Facts

Distributed by: Geiss, Destin & Dunn, Inc.Peachtree City, GA 30269

Otc - Purpose

Active ingredientsPurposesCamphor 4.8%Cough suppressant & topical analgesicEucalyptus oil 1.2%Cough suppressantMenthol 2.6%Cough suppressant & topical analgesic

Uses

  • On chest & throat, temporarily relieves cough due to the common coldon muscles and joints, temporarily relieves minor aches and pains

Warnings

For external use only; avoid contact with eyes.

Do Not Use

  • By mouthwith tight bandagesin nostrilson 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 heatdo not microwavedo not 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 clear up and occur again within a few dayscough lasts more than 7 days, tends to recur, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

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: 800-222-1222.

Directions

  • See important warnings under "When using this product"Adults and children 2 years old and older:rub a thick layer on chest & throat for cough, or rub on sore aching muscles or jointscover with a warm, dry cloth if desiredkeep clothing loose about throat/chest to help vapors reach the nose/mouthrepeat up to three times daily or as directed by a doctorChildren under 2 years: do not use

Other Information

  • Store at 15 to 30°C (59 to 86°F)Tamper Evident: DO NOT USE IF SEAL ON JAR IS BROKEN OR MISSING.

Inactive Ingredients

Cedarleaf oil, nutmeg oil, spirits of turpentine, thymol, white petrolatum

* Please review the disclaimer below.