Medicated Chest Rub
Camphor, Menthol, Eucalyptus Oil
Orazen Inc
Human Otc Drug
NDC 71927-020Medicated Chest Rub also known as Camphor, Menthol, Eucalyptus Oil is a human otc drug labeled by 'Orazen Inc'. National Drug Code (NDC) number for Medicated Chest Rub is 71927-020. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Medicated Chest Rub drug includes Camphor (synthetic) - 4.8 g/100g Eucalyptus Oil - 1.2 g/100g Menthol - 2.6 g/100g . The currest status of Medicated Chest Rub drug is Active.
Drug Information:
| Drug NDC: | 71927-020 |
| 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: | Medicated 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, Menthol, Eucalyptus Oil |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Orazen Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| 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 - 2.6 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: | 14 Feb, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 Dec, 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: | Orazen Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0052548730611
|
| UPC stands for Universal Product Code. |
| 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 NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 71927-020-01 | 50 g in 1 JAR (71927-020-01) | 14 Feb, 2022 | N/A | No |
| 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:
Uses temporarily relieves throat and chest - cough - nasal congestion due to common cold - aching muscles - minor aches and pains keep out of reach of children. in case of of accidental ingestion, get medical help or contact a poison control center immediately. stop use and ask a doctor if muscle aches/pains persist for more than 7 days or come back cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. thes could be signs of a serious condition warnings for external use only do not use - by mouth - in nostrils - on wounds or damaged skin - with light bandages ask a doctor before use if you have - asthma - excessive phlegm (mucus) - emphysema - persistant or chronic cough - cough associated with smoking when using this product do not - heat - microwave - use near open flame - add to hot water or any container where heating water may cause splattering and result in burns if pregnant or breat feeding, ask a health professional before use directions - see important warnings under "when using this product" - children under 2 years of age, ask a doctor before using the product - adults and children 2 years and older. rub a thick layer of on chest and throat or rub on sore aching muscles. if desired cover with a dry soft cloth but keep clothing loose. repeat up to 3 times daily other information store at room temperature inactive ingredients cedar leaf oil, nutmeg oil, paraffin, petrolatum, thymol, turpentine oil
Product Elements:
Medicated chest rub camphor, menthol, eucalyptus oil cedar leaf oil nutmeg oil paraffin petrolatum thymol turpentine camphor (synthetic) camphor (synthetic) menthol menthol eucalyptus oil eucalyptus oil
Indications and Usage:
Stop use and ask a doctor if muscle aches/pains persist for more than 7 days or come back cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. thes could be signs of a serious condition warnings for external use only do not use - by mouth - in nostrils - on wounds or damaged skin - with light bandages ask a doctor before use if you have - asthma - excessive phlegm (mucus) - emphysema - persistant or chronic cough - cough associated with smoking when using this product do not - heat - microwave - use near open flame - add to hot water or any container where heating water may cause splattering and result in burns if pregnant or breat feeding, ask a health professional before use directions - see important warnings under "when using this product" - children under 2 years of age, ask a doctor before using the product - adults and children 2 years and older. rub a thick layer of on chest and throat or rub on sore aching muscles. if desired cover with
Read more... a dry soft cloth but keep clothing loose. repeat up to 3 times daily other information store at room temperature inactive ingredients cedar leaf oil, nutmeg oil, paraffin, petrolatum, thymol, turpentine oil
Warnings:
Warnings for external use only do not use - by mouth - in nostrils - on wounds or damaged skin - with light bandages ask a doctor before use if you have - asthma - excessive phlegm (mucus) - emphysema - persistant or chronic cough - cough associated with smoking when using this product do not - heat - microwave - use near open flame - add to hot water or any container where heating water may cause splattering and result in burns if pregnant or breat feeding, ask a health professional before use directions - see important warnings under "when using this product" - children under 2 years of age, ask a doctor before using the product - adults and children 2 years and older. rub a thick layer of on chest and throat or rub on sore aching muscles. if desired cover with a dry soft cloth but keep clothing loose. repeat up to 3 times daily other information store at room temperature inactive ingredients cedar leaf oil, nutmeg oil, paraffin, petrolatum, thymol, turpentine oil
Dosage and Administration:
Directions - see important warnings under "when using this product" - children under 2 years of age, ask a doctor before using the product - adults and children 2 years and older. rub a thick layer of on chest and throat or rub on sore aching muscles. if desired cover with a dry soft cloth but keep clothing loose. repeat up to 3 times daily other information store at room temperature inactive ingredients cedar leaf oil, nutmeg oil, paraffin, petrolatum, thymol, turpentine oil
Package Label Principal Display Panel:
Medicated chest rub label