Preferred Plus Value Vapor Steam
Camphor (synthetic)
Kinray, Inc.
Human Otc Drug
NDC 61715-256Preferred Plus Value Vapor Steam also known as Camphor (synthetic) is a human otc drug labeled by 'Kinray, Inc.'. National Drug Code (NDC) number for Preferred Plus Value Vapor Steam is 61715-256. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Preferred Plus Value Vapor Steam drug includes Camphor (synthetic) - .623 g/10mL . The currest status of Preferred Plus Value Vapor Steam drug is Active.
Drug Information:
| Drug NDC: | 61715-256 |
| 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: | Preferred Plus Value Vapor Steam |
| 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 (synthetic) |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Kinray, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| 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) - .623 g/10mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | RESPIRATORY (INHALATION)
|
| 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: | 02 Nov, 2011 |
| 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: | Kinray, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 701961
|
| 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
|
| 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 |
|---|
| 61715-256-08 | 1 BOTTLE, PLASTIC in 1 CARTON (61715-256-08) / 237 mL in 1 BOTTLE, PLASTIC | 01 Jul, 2014 | 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:
Purpose cough suppressant
Product Elements:
Preferred plus value vapor steam camphor (synthetic) nutmeg oil poloxamer 124 dimethicone camphor (synthetic) camphor (synthetic) alcohol cedar leaf oil eucalyptus oil laureth-7 menthol
Indications and Usage:
Use temporarily relieves cough ocurring with a cold
Warnings:
Warnings for external use only. flammable. keep away from fire or flame. for steam inhalation only. ask a doctor before use if you have ⢠a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema ⢠cough that ocurs with too much phlegm (mucus) when using this product, do not heat microwave use near an open flame take by mouth direct steam from the vaporizer too close to the face add to hot water or any container where heating water except when adding to cold water only in a hot steam vaporizer. may cause splattering and result in burns. stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. these could be signs of a serious condition. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away. in case of eye exposure, flush with water.
Do Not Use:
Warnings for external use only. flammable. keep away from fire or flame. for steam inhalation only. ask a doctor before use if you have ⢠a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema ⢠cough that ocurs with too much phlegm (mucus) when using this product, do not heat microwave use near an open flame take by mouth direct steam from the vaporizer too close to the face add to hot water or any container where heating water except when adding to cold water only in a hot steam vaporizer. may cause splattering and result in burns. stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. these could be signs of a serious condition. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away. in case of eye exposure, flush with water.
When Using:
When using this product, do not heat microwave use near an open flame take by mouth direct steam from the vaporizer too close to the face add to hot water or any container where heating water except when adding to cold water only in a hot steam vaporizer. may cause splattering and result in burns.
Dosage and Administration:
Directions see important warnings under "when using this product" adults & children 2 years & over: use 1 tablespoon of solution for each quart of water or 1½ teaspoonful of solution for each pint of water add solution directly to cold water only in a hot steam vaporizer follow manufacturer's directions for using vaporizer breathe in the medicated vapors use up to three times daily or as directed by a doctor children under 2 years: ask a doctor
Stop Use:
Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. these could be signs of a serious condition.
Package Label Principal Display Panel:
Principal display panel preferred plus compare to the active ingredient in vicks ® vaposteam ®* medicated vaporizing steam liquid cough suppressant contains camphor liquid medication for hot steam vaporizers increases the acyion of steam for colds relieves cough to help you rest caution: not for internal use medicated vapo steam .jpg