Vaporizing Chest Rub

Camphor, Eucalyptus Oil, Menthol


Kareway Product, Inc.
Human Otc Drug
NDC 67510-0672
Vaporizing Chest Rub also known as Camphor, Eucalyptus Oil, Menthol is a human otc drug labeled by 'Kareway Product, Inc.'. National Drug Code (NDC) number for Vaporizing Chest Rub is 67510-0672. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Vaporizing Chest Rub drug includes Camphor (synthetic) - 4.8 g/100g Eucalyptus Oil - 1.2 g/100g Menthol - 1 g/100g . The currest status of Vaporizing Chest Rub drug is Active.

Drug Information:

Drug NDC: 67510-0672
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Vaporizing Chest Rub
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Camphor, Eucalyptus Oil, Menthol
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Kareway Product, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Gel
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:CAMPHOR (SYNTHETIC) - 4.8 g/100g
EUCALYPTUS OIL - 1.2 g/100g
MENTHOL - 1 g/100g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: OTC MONOGRAPH FINAL
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date: 09 Sep, 2011
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 16 Jan, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: part341
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.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Kareway Product, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:1188395
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UNII:5TJD82A1ET
2R04ONI662
L7T10EIP3A
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
67510-0672-4100 g in 1 JAR (67510-0672-4)09 Sep, 2011N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Purpose:

Purpose cough suppressant and topical analgesic cough suppressant cough suppressant and topical analgesic

Product Elements:

Vaporizing chest rub camphor, eucalyptus oil, menthol nutmeg oil petrolatum thuja occidentalis bark thymol turpentine camphor (synthetic) camphor (synthetic) menthol menthol eucalyptus oil eucalyptus oil

Indications and Usage:

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

Warnings:

Warnings for external use only; avoid contact with eyes. do not use by mouth with tight bandages in nostrils 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 add to hot water or any container where heating water. may cause splattering and result in burns. stop use and ask a doctor if if you experience: muscle aches and pains persist more than 7 days or come back cough lasts for 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 right away.

Do Not Use:

Warnings for external use only; avoid contact with eyes. do not use by mouth with tight bandages in nostrils 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 add to hot water or any container where heating water. may cause splattering and result in burns. stop use and ask a doctor if if you experience: muscle aches and pains persist more than 7 days or come back cough lasts for 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 right away.

When Using:

When using this product, do not heat microwave add to hot water or any container where heating water. may cause splattering and result in burns.

Dosage and Administration:

Directions see important warnings under "when using this product" adults and children 2 years and over: apply 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 3 times per 24 hours or as directed by doctor children under 2 years: do not use

Stop Use:

Stop use and ask a doctor if if you experience: muscle aches and pains persist more than 7 days or come back cough lasts for more than 7 days, comes back or occurs with fever, rash or persistent headache. these could be signs of a serious condition.

Package Label Principal Display Panel:

Package label vaporizing chest rub [image of carton label] carton


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.