NDC 72914-0001 Painshield

Menthol

NDC Product Code 72914-0001

NDC Product Information

Painshield with NDC 72914-0001 is a a human over the counter drug product labeled by Nutranext Llc. The generic name of Painshield is menthol. The product's dosage form is cream and is administered via topical form.

Labeler Name: Nutranext 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.

Painshield 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 3.7 g/100g

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.

  • ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • 2-(2-(2-(2-PHENOXYETHOXY)ETHOXY)ETHOXY)ETHANOL (UNII: Y050HYR4XA)
  • WATER (UNII: 059QF0KO0R)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • ETHYLPARABEN (UNII: 14255EXE39)
  • BUTYLPARABEN (UNII: 3QPI1U3FV8)

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: Nutranext Llc
Labeler Code: 72914
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: 03-15-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Painshield Product Label Images

Painshield 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

Otc - Active Ingredient

Active ingredient Menthol USP 3.7%

Otc - Purpose

Purpose Topical analgesic

Indications & Usage

  • Uses temporarily relieves minor aches and pains of muscles and joints due to
  • Arthritissimple backachesstrainsbruisessprains

Warnings

WarningsFor external use only Flammable: Keep away from fire or flame.

Otc - Do Not Use

  • Do not use on wounds or damaged skinwith a heating pad with other ointments, creams, sprays or liniments

Otc - When Using

  • When using this productavoid contact with eyesdo not bandage tightlywash hands with cool water after use

Otc - Stop Use

  • Stop use and ask a doctor ifcondition worsens or rash or irritation developssymptoms last more than 7 dayscondition clears up and occurs again within a few days

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Dosage & Administration

Directionsadults and children 12 years of age and older: apply and massage onto affected area no more than 3 to 4 times daily
children under 12 years of age: ask a doctor

Other Safety Information

  • Other informationclose cap tightlystore in a cool, dry place

Inactive Ingredient

Inactive ingredients Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Carbomer, Dimethyl Sulfone(MSM), EDTA, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Melaleuca Altemifolia (Tea Tree) Leaf Oil, Pyridoxine HCl (Vitamins B6), Phenoxyethanol & Methyl/Ethyl/Butyl/Propyl/Isobutylparabens, Polysorbate 20, Purified Water, Tocopheryl (Vitamin E) Acetate, Triethanolamine

Other

Manufactured and Distributed by Stop Aging Now as Nutranext Direct, LLC1301 Sawgrass Corporate Parkway, Sunrise, FL 33323 • 800-627-9721NDC# 72914-0001-1

* Please review the disclaimer below.

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