Super White Stuff Pain Relief
Menthol
Blue Spring Wellness, L.l.c.
Human Otc Drug
NDC 14448-302Super White Stuff Pain Relief also known as Menthol is a human otc drug labeled by 'Blue Spring Wellness, L.l.c.'. National Drug Code (NDC) number for Super White Stuff Pain Relief is 14448-302. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Super White Stuff Pain Relief drug includes Menthol - 14 mg/mL . The currest status of Super White Stuff Pain Relief drug is Active.
Drug Information:
| Drug NDC: | 14448-302 |
| 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: | Super White Stuff 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: | Blue Spring Wellness, L.l.c. |
| 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 - 14 mg/mL
|
| 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 Aug, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 05 May, 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: | BLUE SPRING WELLNESS, L.L.C.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 2391332
|
| 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: | 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 |
|---|
| 14448-302-30 | 85 mL in 1 BOTTLE (14448-302-30) | 01 Aug, 2020 | 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 topical analgesic
Product Elements:
Super white stuff pain relief menthol carbomer interpolymer type a (allyl sucrose crosslinked) aloe vera leaf water arnica montana flower ascorbyl palmitate calendula officinalis flower caprylyl glycol chamomile tanacetum parthenium whole coriander emu oil hamamelis virginiana root bark/stem bark lamium album whole dimethyl sulfone phenoxyethanol salix nigra bark sodium cocoyl isethionate sodium hydroxide sorbitol edetate sodium tilia cordata whole .alpha.-tocopherol acetate vitis vinifera seed menthol menthol
Indications and Usage:
Uses for the temporary relief of minor aches and pains associated with arthritis simple backahe sprains strains bruises
Warnings:
Warnings: for external use only do not use on wounded, damaged or irritated skin. when using this product avoid contact with eyes or mucous membranes. do not bandage tightly stop use and ask a doctor if you experience a rash and/or a reaction condition worsens or if symptoms persist for more than 10 days or clears up and occur again within a few days. if pregnant or breast-feeding ask a health professional before use. consult a doctor before use on children under 12 years of age if arthritis conditions are present. for all other listed uses, consult a doctor before use on children under 2 years of age. 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 do not use on wounded, damaged or irritated skin. when using this product avoid contact with eyes or mucous membranes. do not bandage tightly stop use and ask a doctor if you experience a rash and/or a reaction condition worsens or if symptoms persist for more than 10 days or clears up and occur again within a few days. if pregnant or breast-feeding ask a health professional before use. consult a doctor before use on children under 12 years of age if arthritis conditions are present. for all other listed uses, consult a doctor before use on children under 2 years of age. 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 avoid contact with eyes or mucous membranes. do not bandage tightly
Dosage and Administration:
Directions apply to affected area not more than 3 to 4 times a days. consult a doctor before using for children under 12 for arthritic conditions and for all children under 2 years of age for all other uses.
Stop Use:
Stop use and ask a doctor if you experience a rash and/or a reaction condition worsens or if symptoms persist for more than 10 days or clears up and occur again within a few days.
Package Label Principal Display Panel:
Package labeling:85ml label
Further Questions:
Questions or comments? call 1-800-452-3700 or visit www.bluestuff.com