Lusti Therapeutic Ice Analgesic Rub
Menthol, Camphor
New Life Products, Inc.
Human Otc Drug
NDC 49681-010Lusti Therapeutic Ice Analgesic Rub also known as Menthol, Camphor is a human otc drug labeled by 'New Life Products, Inc.'. National Drug Code (NDC) number for Lusti Therapeutic Ice Analgesic Rub is 49681-010. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Lusti Therapeutic Ice Analgesic Rub drug includes Camphor (synthetic) - .031 g/g Menthol, Unspecified Form - .015 g/g . The currest status of Lusti Therapeutic Ice Analgesic Rub drug is Active.
Drug Information:
| Drug NDC: | 49681-010 |
| 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: | Lusti Therapeutic Ice Analgesic 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: | Menthol, Camphor |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | New Life Products, 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) - .031 g/g
MENTHOL, UNSPECIFIED FORM - .015 g/g
|
| 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 NOT 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: | 24 Mar, 2010 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 Jun, 2026 |
| 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: | part348 |
| 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, 2024 |
| 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: | New Life Products, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1310054
|
| 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
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 |
|---|
| 49681-010-10 | 284 g in 1 JAR (49681-010-10) | 24 Mar, 2010 | 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:
Otc - purpose section topical analgesic. temporarily relieves the minor aches and paiins associated with simple backache, arthritis, sprains, strains and bruises.
Product Elements:
Lusti therapeutic ice analgesic rub menthol, camphor menthol, unspecified form menthol, unspecified form camphor (synthetic) camphor (synthetic) water propylene glycol mineral oil carbomer homopolymer type b (allyl sucrose crosslinked) trolamine methylparaben propylparaben dmdm hydantoin fd&c blue no. 1
Indications and Usage:
Use: temporarily relieves the minor aches and pains associated with simple backache, arthritis, sprains, and bruises.
Warnings:
Warnings section for external use only
Do Not Use:
Warnings section for external use only
When Using:
Otc - when using section avoid contact with eyes or mucous membranes. if contact occurs, rinse thoroughly with water.
Dosage and Administration:
Directions section apply liberally to painful area and massage until gel is absorbed into the skin. repeat three to four times daily.
Stop Use:
Otc - stop use section stop use of this product and consult a doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again or excessive skin irritation occurs.
Package Label Principal Display Panel:
Package label. bonus size lusti professional therapeutic ice analgesic rub net wt. 10 oz. e 284g deep penetrating greaseless pain relief fast relief from minor arthritis, backache, muscle, and joint pain
Further Questions:
Otc - questions section questions or comments: www.jflabs.com jf labs, inc. chicago, illinois 60629