NDC 14448-314 Super Blue Stuff Pain Relief Cream
Menthol Cream Topical

Product Information

Super Blue Stuff Pain Relief Cream is a human over the counter drug product labeled by Blue Spring Wellness, L.l.c.. The generic name of Super Blue Stuff Pain Relief Cream is menthol. The product's dosage form is cream and is administered via topical form.

Product Code14448-314
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Super Blue Stuff Pain Relief Cream
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Menthol
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Otc Drug
Dosage FormCream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Blue Spring Wellness, L.l.c.
Labeler Code14448
FDA Application Number What is the FDA Application Number?
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.
part348
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
11-22-2020
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2022
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Super Blue Stuff Pain Relief Cream?


Product Packages

NDC 14448-314-03

Package Description: 85 mL in 1 CYLINDER

NDC 14448-314-04

Package Description: 118 mL in 1 JAR

NDC 14448-314-12

Package Description: 355 mL in 1 CYLINDER

NDC 14448-314-17

Package Description: 5 mL in 1 PACKET

Product Details

What are Super Blue Stuff Pain Relief Cream Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Super Blue Stuff Pain Relief Cream Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Super Blue Stuff Pain Relief Cream Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

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Super Blue Stuff Pain Relief Cream Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredient:



Menthol, USP (1.4%)


Purpose:



Topical Analgesic


Uses:



Temporary relief of minor aches and pains associated with arthritis, simple backache, sprains, strains and bruises.


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.


Directions:



Apply to affected area not more than 3 or 4 time a day.


Other Information:



Store at room temperature.


Inactive Ingredients:



Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf(Aloe Vera Gel)Juice, Anthemis Nobilis (Roman Chamomile) Oil, Aqua (Deionized Water), Arnica Montana Flower Extract, Ascorbyl Palmitate (Vitamin C), Calendula Officinalis Extract, Caprylyl Glycol, Centraurea Cyanus (Cornflower) Extract, Coriandrum Sativum (Coriander) Oil, Emu Oil, Hamamelis Virginiana (Witch Hazel), Lamium Album (White Nettle) Extract, Methylsulfonylmethane (MSM), Parfum (Fragrance), Phenoxyethanol, Sali Nigra (Willow) Bark Extract, Sodium Cocoyl Isethionate, Sodium Hydroxide, Sorbitol, Tetrasodium EDTA, Tilia Cordata (Linden)Extract, Tocopheryl Acetate (Vitamin E), Vitis Vinifera (Grape) Seed Extract, FD&C Blue #1


Questions Or Comments?



1-800-452-3700 or www.bluespringwellness.com


Package Labeling:85Ml




Package Labeling:118Ml




Package Labeling:355Ml




* Please review the disclaimer below.