Super Blue Stuff Pain Relief Cream
Menthol
Blue Spring Wellness, L.l.c.
Human Otc Drug
NDC 14448-314Super Blue Stuff Pain Relief Cream also known as Menthol is a human otc drug labeled by 'Blue Spring Wellness, L.l.c.'. National Drug Code (NDC) number for Super Blue Stuff Pain Relief Cream is 14448-314. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Super Blue Stuff Pain Relief Cream drug includes Menthol - 14 mg/mL . The currest status of Super Blue Stuff Pain Relief Cream drug is Active.
Drug Information:
| Drug NDC: | 14448-314 |
| 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 Blue Stuff Pain Relief Cream |
| 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: | 22 Nov, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 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: | 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. |
| UPC: | 0673314001294
0673314001881
0673314001898
|
| 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 |
|---|
| 14448-314-03 | 85 mL in 1 CYLINDER (14448-314-03) | 22 Nov, 2020 | N/A | No |
| 14448-314-04 | 118 mL in 1 JAR (14448-314-04) | 22 Nov, 2020 | N/A | No |
| 14448-314-12 | 355 mL in 1 CYLINDER (14448-314-12) | 22 Nov, 2020 | N/A | No |
| 14448-314-17 | 5 mL in 1 PACKET (14448-314-17) | 01 Jun, 2021 | 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 blue stuff pain relief cream menthol carbomer interpolymer type a (allyl sucrose crosslinked) aloe vera leaf chamaemelum nobile flower oil water arnica montana flower ascorbyl palmitate calendula officinalis flower caprylyl glycol centaurea cyanus flower coriander oil emu oil hamamelis virginiana top 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 fd&c blue no. 1 menthol menthol
Indications and Usage:
Uses: temporary relief of minor aches and pains associated with arthritis, simple backache, sprains, strains and 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 occurs 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 if arthritis conditions are present. for all other listed uses, consult a doctor before use on children under 2. 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 occurs 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 if arthritis conditions are present. for all other listed uses, consult a doctor before use on children under 2. 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 or 4 time a day.
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 occurs again within a few days.
Package Label Principal Display Panel:
Package labeling:85ml bottle
Package labeling:118ml bottle2
Package labeling:355ml bottle3
Package labeling: 5ml pack
Further Questions:
Questions or comments? 1-800-452-3700 or www.bluespringwellness.com