NDC 80223-001 Paingone Freeze

Menthol

NDC Product Code 80223-001

NDC 80223-001-01

Package Description: 200 mL in 1 TUBE

NDC Product Information

Paingone Freeze with NDC 80223-001 is a a human over the counter drug product labeled by Quality Health Innovations Limited. The generic name of Paingone Freeze is menthol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Quality Health Innovations Limited

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Paingone Freeze 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 4 g/100mL

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.

  • ALCOHOL (UNII: 3K9958V90M)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)

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.
  • 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: Quality Health Innovations Limited
Labeler Code: 80223
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: 09-01-2020 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: 12-31-2021 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.

Paingone Freeze Product Label Images

Paingone Freeze 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   4%

Purpose

Pain relieving gel

Uses

For temporary pain relief associated with sprains, strains, backache, arthritis and aching muscles and joints.

Warnings

For external use only.In case of ingestion seek medical assistance.If a rash appears, discontinue use.Do not use:• if you are allergic to any of the ingredients• on inflamed or broken skin• around the eyes• with other topical treatments• under bandages or occlusive dressings• on children under the age of 12Consult your doctor or pharmacist before use if you are diabetic, pregnant or breastfeeding, have poor circulation, a skin condition or if symptoms persists.

Directions

  • Adults and children 12 years and older:Apply a small amount to the affected area and massage gently, no more than 4 times per day. Wash hands with cool water after use.

Other Information

  • Store in a cool dry place.Keep out of sight and reach of children.Once opened use within 12 months.

Inactive Ingredient

Water, Alcohol Denat., Polysorbate-20,Glycerin, Propylene Glycol, Triethanolamine,Phenoxyethanol, Acrylates/C10-30 Alkyl AcrylateCrosspolymer, Cinnamomum Camphora (Camphor)bark oil, Ethylhexylglycerin, Limonene, Linalool, Cl 42090(FD&C Blue 1), CL17200 (D&C Red 33)

* Please review the disclaimer below.