Lightning Pain Relief
Menthol
Clinical Resolution Laboratory, Inc.
Human Otc Drug
NDC 63742-013Lightning Pain Relief also known as Menthol is a human otc drug labeled by 'Clinical Resolution Laboratory, Inc.'. National Drug Code (NDC) number for Lightning Pain Relief is 63742-013. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Lightning Pain Relief drug includes Menthol - 40 mg/g . The currest status of Lightning Pain Relief drug is Active.
Drug Information:
| Drug NDC: | 63742-013 |
| 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: | Lightning Pain Relief |
| 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 |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Clinical Resolution Laboratory, 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: | MENTHOL - 40 mg/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: | 01 May, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 18 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, 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: | Clinical Resolution Laboratory, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1148430
|
| 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. |
| UPC: | 0850011668054
0850011668023
|
| UPC stands for Universal Product Code. |
| UNII: | 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 |
|---|
| 63742-013-00 | 65 g in 1 BOTTLE (63742-013-00) | 01 May, 2019 | N/A | No |
| 63742-013-01 | 101 g in 1 BOTTLE (63742-013-01) | 01 May, 2019 | 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 cooling pain relief
Product Elements:
Lightning pain relief menthol carbomer interpolymer type a (allyl sucrose crosslinked) allantoin aloe vera leaf arnica montana flower indian frankincense shea butter c13-14 isoparaffin cannabis sativa seed oil carboxypolymethylene centella asiatica leaf cholesterol dimethicone dimethyl isosorbide glycyrrhizinate dipotassium edetate disodium anhydrous emu oil diethylene glycol monoethyl ether eucalyptus oil glycerin glyceryl monostearate sunflower oil isopropyl myristate laureth-7 lavender oil tea tree oil peg-100 stearate phenoxyethanol polysorbate 20 water pyridoxine hydrochloride sodium benzoate .alpha.-tocopherol acetate menthol menthol
Indications and Usage:
Uses: temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains and sprains.
Warnings:
Warnings (for external use only) do not use this product if tamper-evident "do not use this product" if safety seal is broken or missing. pregnant or breastfeeding, ask a health professional before use. when using this product avoid contact with the eyes or mucous membranes do not use with other ointments, creams, sprays or liniments do not apply to irritated skin or if excessive irritation develops do not apply to wounds or damaged skin do not use with heating pad or device do not bandage stop use and ask a doctor if condition worsens, or if symptoms persist more than 7 days, or clear up and reoccur. keep out of reach of children if swallowed, call your poison control center at 1 (800) 222-1222.
Do Not Use:
Warnings (for external use only) do not use this product if tamper-evident "do not use this product" if safety seal is broken or missing. pregnant or breastfeeding, ask a health professional before use. when using this product avoid contact with the eyes or mucous membranes do not use with other ointments, creams, sprays or liniments do not apply to irritated skin or if excessive irritation develops do not apply to wounds or damaged skin do not use with heating pad or device do not bandage stop use and ask a doctor if condition worsens, or if symptoms persist more than 7 days, or clear up and reoccur. keep out of reach of children if swallowed, call your poison control center at 1 (800) 222-1222.
When Using:
When using this product avoid contact with the eyes or mucous membranes do not use with other ointments, creams, sprays or liniments do not apply to irritated skin or if excessive irritation develops do not apply to wounds or damaged skin do not use with heating pad or device do not bandage
Dosage and Administration:
Directions adults and children 12 years of age and older: apply liberally to the affected area(s) and continue to massage in thoroughly for 1-2 minutes until it has been absorbed. for best results, apply 2-3 times daily or as needed. children under 12 years of age, consult a doctor.
Stop Use:
Stop use and ask a doctor if condition worsens, or if symptoms persist more than 7 days, or clear up and reoccur.
Package Label Principal Display Panel:
Lightning pain relief cream, 2.28 fl.oz/ 65g (63742-013-00) 65
Lightning pain relief cream, 3.56 fl.oz/101g (63742-013-01) 101