NDC 72189-286 Calypxo Pain Relief

Methyl Salicylate, Menthol Cream

NDC Product Code 72189-286

NDC 72189-286-04

Package Description: 113 g in 1 BOTTLE

NDC Product Information

Calypxo Pain Relief with NDC 72189-286 is a a human over the counter drug product labeled by Directrx. The generic name of Calypxo Pain Relief is methyl salicylate, menthol cream. 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.

Calypxo 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.

  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)

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: Directrx
Labeler Code: 72189
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: 10-26-2021 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.

Calypxo Pain Relief Product Label Images

Calypxo 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

Other

Drugs Facts

Otc - Active Ingredient

Methyl Salicylate………10.00%Menthol…………………3.00%

Otc - Purpose

Topical AnalgesicTopical Analgesic

Indications & Usage

For temporary relief of minor aches and pains associated with simple backaches, arthritis, bruises, sprains and cramps.

Warnings

For external use only.Avoid contact with eyes and mucous membranes.Do not bandage tightly or cover treated areas.Do not use with heating pad.Do not apply to open wounds or damages skin.A mild burning sensation may occur. If severe burning sensation occurs, discontinue use immediately.If symptoms persist for more than seven days, discontinue use and consult physician.Keep out of reach of children. If swallowed, consult physician.If pregnant or breast feeding, contact physician prior to use.

Storage And Handling

Store at room temperature.

Inactive Ingredient

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetyl Alcohol, Diazolidinyl Urea, Isopropyl Myristate, Methyl Paraben, PEG-8, Propyl Paraben, Propylene Glycol, Sodium lauryl Sulfate, Triethanolamine.

Dosage & Administration

For adults apply directly to affected area. Repeat as necessary, but do not use more than 3-4 times daily.

* Please review the disclaimer below.