NDC 82262-224 Gaspari Ageless Pain Relief Cream

Menthol

NDC Product Code 82262-224

NDC 82262-224-00

Package Description: 118 mL in 1 BOTTLE

NDC Product Information

Gaspari Ageless Pain Relief Cream with NDC 82262-224 is a a human over the counter drug product labeled by Gaspari Anti-aging Llc. The generic name of Gaspari Ageless Pain Relief Cream is menthol. The product's dosage form is cream and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1102253.

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.

Gaspari Ageless Pain Relief Cream 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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • BROMELAINS (UNII: U182GP2CF3)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • TAMANU OIL (UNII: JT3LVK84A1)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETYL MYRISTOLEATE (UNII: 87P8K33Q5X)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • BERGAMOT OIL (UNII: 39W1PKE3JI)
  • EMU OIL (UNII: 344821WD61)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • LAURETH-7 (UNII: Z95S6G8201)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • PAPAIN (UNII: A236A06Y32)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • SALIX ALBA BARK (UNII: 205MXS71H7)
  • SESAME OIL UNSAPONIFIABLES (UNII: K9GA601CEG)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • COCOA (UNII: D9108TZ9KG)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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: Gaspari Anti-aging Llc
Labeler Code: 82262
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: 09-20-2021 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".

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Gaspari Ageless Pain Relief Cream Product Label Images

Gaspari Ageless Pain Relief Cream 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 Ingredients

Menthol 2.00%

Purpose

Tropical Analgesic

Uses:

  • For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains.

Warnings:

  • For external use only

Do Not Use

  • On damaged or broken skin.

When Using This Product

  • Avoid contact with the eyes.Do not bandage tightly.

Stop Use And Ask A Doctor If

Rash or irritation develops and lasts. condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within few days.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breat-feeding. ask a health professional before use

Directions:

  • Adults and children 2 years of age and older: Apply to affected area not ore than 3 to 4 times daily.Children under 2 years of age: consult a doctor.

Other Inforation:

  • Avoid contact with the eyes.Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Bromelain, Butyrospermum Parikii (Shea) Butter, Calophyllum Tacamahaca (Tamanu) Oil, Camellia Sinensis (Green Tea) Extract, Cetearyl Alcohol, Cetyl Myristoleate, Chondroitin Sulfate, Citric Acid, Citrus Aurantium Bergamia (Bergamot) Oil, Emu Oil, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Laureth-7, Melia Azadirachta (Neem) Oil, Mentha Piperita (Peppermint) Oil, Methylsulfonylmethane (MSM), Papain, Phenoxyethanol, Polyacrylamide, Polysorbate 20, Salix Alba (Willow) Bark Extract, SD-Alcohol 40B, Sesamum Indicum (Sesame) Oil, Stearic Acid, Theobroma Cacao (Cocoa) Butter, Tocopheryl Acetate (Vitamin E), Xanthan Gum.

Questions?

1-908-461-2564

* Please review the disclaimer below.