NDC 14448-316 Blue Spring Foot And Leg Comfort Cream With Pain Relief

Menthol, Capsaicin

NDC Product Code 14448-316

NDC CODE: 14448-316

Proprietary Name: Blue Spring Foot And Leg Comfort Cream With Pain Relief 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.

Non-Proprietary Name: Menthol, Capsaicin 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.

NDC Code Structure

  • 14448 - Blue Spring Wellness, L.l.c.
    • 14448-316 - Blue Spring Foot And Leg Comfort Cream With Pain Relief

NDC 14448-316-00

Package Description: 227 g in 1 JAR

NDC Product Information

Blue Spring Foot And Leg Comfort Cream With Pain Relief with NDC 14448-316 is a a human over the counter drug product labeled by Blue Spring Wellness, L.l.c.. The generic name of Blue Spring Foot And Leg Comfort Cream With Pain Relief is menthol, capsaicin. The product's dosage form is cream and is administered via topical form.

Dosage Form: Cream - 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.

Product Type: Human Otc Drug 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.

Blue Spring Foot And Leg Comfort Cream With Pain Relief Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CHAMAEMELUM NOBILE WHOLE (UNII: 7NF3GE7IWR)
  • WATER (UNII: 059QF0KO0R)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)
  • CHAMOMILE (UNII: FGL3685T2X)
  • CORIANDER (UNII: 1OV56052IK)
  • EMU OIL (UNII: 344821WD61)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • WITCH HAZEL (UNII: 101I4J0U34)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB)
  • LAMIUM ALBUM WHOLE (UNII: 046Y1357I6)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SALIX ALBA BARK (UNII: 205MXS71H7)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SORBITOL (UNII: 506T60A25R)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • TANACETUM PARTHENIUM WHOLE (UNII: 6GE7Z0761K)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

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.

Labeler Name: Blue Spring Wellness, L.l.c.
Labeler Code: 14448
FDA Application Number: part348 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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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.

Start Marketing Date: 10-25-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 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.

Exclude Flag: N - NO 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".

* Please review the disclaimer below.

Blue Spring Foot And Leg Comfort Cream With Pain Relief Product Label Images

Blue Spring Foot And Leg Comfort Cream With Pain Relief Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient:

Menthol, USP (1.5%), Capsaicin (0.025%)

Purpose:

  • Topical Analgesic

Uses:

  • Temporary relief of minor aches and pains of muscles and joints.

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 bandaged 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 clear up and occur again within a few days.

If Pregnant Or Breast-Feeding

Ask a health professional before use.

Keep Out Of Reach Of Children.

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

  • For adults and children 2 years of age and older: apply to affected area not more than 3 or 4 times a day. Consult a doctor before using for children under 2 years of age.

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, Centaurea Cyanus (Cornflower) Extrat, Chamomilla Recutita (Chamomile) Extract, Coriandrum Satiyum (Coriander) Oil, Emu Oil, Ethylhexylglycerin, Hamamelis Virgiana (Witch Hazel), Helianthus Annuus (Sunflower) Oil, Hypericum Perforatum (St. John's Wort), Lamium Album (White Nettle) Extract, Methylsulfony Methane (MSM), Parfum (Fragrance), Phenoxyethanol, Salix Alba (Willow) Bark Extract, SD-Alcohol 40B, Sodium Lauryl Sulfate, Sorbitol, Tillia Cordata (Linden) Bark Extarct, Triethanolamine, Fever Few Extract, FD&C Blue#1, FD&C Yellow #5.

* Please review the disclaimer below.