NDC 33992-7992 Assured Vaporizing Chest Rub

Camphor And Eucalyptus Oil And Menthol

NDC Product Code 33992-7992

NDC Code: 33992-7992

Proprietary Name: Assured Vaporizing Chest Rub 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: Camphor And Eucalyptus Oil And Menthol 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
  • 33992 - Greenbrier International, Inc.
    • 33992-7992 - Assured Vaporizing Chest Rub

NDC 33992-7992-4

Package Description: 113 g in 1 JAR

NDC Product Information

Assured Vaporizing Chest Rub with NDC 33992-7992 is a a human over the counter drug product labeled by Greenbrier International, Inc.. The generic name of Assured Vaporizing Chest Rub is camphor and eucalyptus oil and menthol. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Greenbrier International, 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.


Assured Vaporizing Chest Rub 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 (SYNTHETIC) 4.7 g/100g
  • EUCALYPTUS OIL 1.2 g/100g
  • MENTHOL 1.25 g/100g

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.

  • PETROLATUM (UNII: 4T6H12BN9U)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • NUTMEG OIL (UNII: Z1CLM48948)
  • TURPENTINE OIL (UNII: C5H0QJ6V7F)
  • CEDAR LEAF OIL (UNII: BJ169U4NLG)
  • THYMOL (UNII: 3J50XA376E)

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: Greenbrier International, Inc.
Labeler Code: 33992
FDA Application Number: part341 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 01-18-2019 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.

Assured Vaporizing Chest Rub Product Label Images

Assured Vaporizing 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

Otc - Active Ingredient

Active IngredientsCamphor            4.7%Eucalyptus Oil    1.2%Menthol            1.25%

Otc - Purpose

PurposeCough Suppressant & Topical analgesicCough SuppressantCough Suppressant & Topical analgesic

Indications & Usage

  • Usesuse on chest and throat to temporarily relieve coughuse on aching muscles to temporarily relieve minor aches and pains

Warnings

WarningsFor external use only; Do not take by mouth or place in nostrils. Avoid excessive heat. Never expose this product to flame or place in any container in which you are heating water. Never place in microwave oven.

Otc - Ask Doctor

Consult a doctor and discontinue use;If cough persist for more than 1 week, tends to recur or is accompanied by fever, rash or persistent headache.

Otc - Keep Out Of Reach Of Children

Keep out of reach of childrenIn case of accidental ingestion, seek professional assistance or contact a Poison Control Centre immediately.

Dosage & Administration

  • Directions:Adults and children over 2 years of age; Rub a thick layer on chest and throat to provide temporary relief from nasal congestion and coughing due to colds. If desired, cover with dry, warm cloth, but keep clothing loose to let the vapours rise to nose and mouth. Repeat up to three times daily, especially at bedtime, or as directed by a doctor.Children under two years of age, consult a doctor.

Inactive Ingredient

Inactive Ingredients:Petrolatum, Mineral Oil, Nutmeg Oil, Spirits of Turpentine, Cedarleaf Oil, Thymol

* Please review the disclaimer below.

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