NDC 14448-315 Super White Stuff Pain Relief

Menthol

NDC Product Code 14448-315

NDC 14448-315-00

Package Description: 5 mL in 1 PACKET

NDC Product Information

Super White Stuff Pain Relief with NDC 14448-315 is a a human over the counter drug product labeled by Blue Spring International, Llc. The generic name of Super White Stuff Pain Relief is menthol. The product's dosage form is cream and is administered via topical form.

Labeler Name: Blue Spring International, Llc

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.

Super White Stuff 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.

  • MENTHOL 14 mg/mL

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 FLOWER OIL (UNII: UB27587839)
  • WATER (UNII: 059QF0KO0R)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)
  • CHAMOMILE (UNII: FGL3685T2X)
  • TANACETUM PARTHENIUM WHOLE (UNII: 6GE7Z0761K)
  • CORIANDER OIL (UNII: 7626GC95E5)
  • EMU OIL (UNII: 344821WD61)
  • HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)
  • LAMIUM ALBUM WHOLE (UNII: 046Y1357I6)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SALIX NIGRA BARK (UNII: QU52J3A5B3)
  • SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SORBITOL (UNII: 506T60A25R)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • TILIA CORDATA WHOLE (UNII: W5E5UB44GD)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • VITIS VINIFERA SEED (UNII: C34U15ICXA)

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 International, Llc
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: 04-19-2021 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.

Super White Stuff Pain Relief Product Label Images

Super White Stuff 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 (1.4%)

Purpose:

Topical Analgesic

Uses:

Temporary relief of minor aches and pains associsted 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 Breat-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, Chamomilla Recutita (Chamomile) Extract, Chrysanthemum Parthenium (Feverfew) Extract, Coriandrum Sativum (Coriander) Oil, Emu Oil, Hamamelis Virginiana (Witch Hazel), Lamium Album (White Nettle) Extract, Methylsulfonylmethane (MSM), Phenoxyethanol, Salix Nigra (Willow) Bark Extract, Sodium Cocoyl Isethionate, Sodium Hydroxide, Sorbitol, Tetrasodium EDTA, Tilia Cordata (Linden) Extract, Tocopheryl Acetate (Vitamin E), Vitis Vinifera (Grape) Seed Extarct.

* Please review the disclaimer below.