NDC 69544-152 Algomend Pain Relief
Menthol Cream Topical

Product Information

Algomend Pain Relief is a human over the counter drug product labeled by Cytosome Llc. The generic name of Algomend Pain Relief is menthol. The product's dosage form is cream and is administered via topical form.

Product Code69544-152
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Algomend Pain Relief
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Menthol
Product Type 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.
Human Otc Drug
Dosage FormCream - 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.
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.
Cytosome Llc
Labeler Code69544
FDA Application Number 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.
part348
Marketing Category 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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
01-21-2015
Listing Expiration Date 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.
12-31-2022
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Algomend Pain Relief?


Product Packages

NDC 69544-152-01

Package Description: 59 mL in 1 JAR

Product Details

What are Algomend Pain Relief Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • FRANKINCENSE OIL (UNII: 67ZYA5T02K)
  • CARBOMER 1342 (UNII: 809Y72KV36)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLYCINE (UNII: TE7660XO1C)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • CHOLINE CHLORIDE (UNII: 45I14D8O27)
  • PROLINE (UNII: 9DLQ4CIU6V)
  • LYSINE (UNII: K3Z4F929H6)
  • MAGNESIUM SULFATE (UNII: DE08037SAB)
  • MALIC ACID (UNII: 817L1N4CKP)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • ROSA CANINA FLOWER OIL (UNII: DUY7M48I1T)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • PROPANEDIOL (UNII: 5965N8W85T)

* Please review the disclaimer below.

Algomend Pain Relief Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredients



Menthol             2.00%


Purpose



External Analgesic


Use



For temporary relief of minor muscle and joint aches and pains associated with arthritis, simple backache, bruises, strains and sprains.


Warnings:



For external use only. Avoid contact with eyes. Do not apply to open wounds or damaged skin. Do not bandage tightly.


Keep Out Of Reach Of Children.



If swallowed, consult physician.


Otc - Stop Use



If symptoms persist for more than seven days, discontinue use and consult physician.


Otc - Ask Doctor



If pregnant or breast feeding, contact physcian prior to use.


Directions:



Apply directly to effected area. Do not use more than four times per day.


Other Ingredients



Aqua (Deionized Water), BUTYROSPERMUM PARKII (SHEA) BUTTER, CAMPHOR, CARBOMER, DIAZOLIDINYL UREA, Emulsifying Wax NF, EUCALYPTUS GLOBULUS LEAF OIL, Glyceryl Sterate, HELIANTHUS ANNUUS (SUNFLOWER) Oil, PEG-100 STERATE, POLYSORBATE-20, TRIETHANOLAMINE.


Other



Distributed by:

Cytosome LLC, Conyers, GA 30013

[email protected]www.algomend.com


Package Label



ALGOMEND

Pain Relief to Help Keep You Moving

* Please review the disclaimer below.