NDC 55628-1001 Ultra Therapy Pain Relief

Menthol, Methyl Salicylate, Capsaicin

NDC Product Code 55628-1001

NDC 55628-1001-2

Package Description: 120 mL in 1 TUBE

NDC Product Information

Ultra Therapy Pain Relief with NDC 55628-1001 is a a human over the counter drug product labeled by Cal Pharma. The generic name of Ultra Therapy Pain Relief is menthol, methyl salicylate, capsaicin. The product's dosage form is lotion and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1372560.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Ultra Therapy 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.

  • CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
  • PETASITES HYBRIDUS LEAF (UNII: JOS311ZC1G)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • MARITIME PINE (UNII: 50JZ5Z98QY)
  • ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ZANTHOXYLUM BUNGEANUM WHOLE (UNII: WH9894JM8K)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • WATER (UNII: 059QF0KO0R)
  • WILLOW BARK (UNII: S883J9JDYX)
  • GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)

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: Cal Pharma
Labeler Code: 55628
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: 11-29-2012 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 - 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.

Ultra Therapy Pain Relief Product Label Images

Ultra Therapy 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

Otc - Active Ingredient

METHYL SALICYLATE (28%)MENTHOL (10%)CAPSAICIN (0.025%)

Otc - Purpose

TOPICAL ANALGESIC

Indications & Usage

USE- TEMPORARILY RELIEVES MILD ACHES AND PAINS OF MUSCLE AND JOINTS

Warnings

WARNINGSFOR EXTERNAL USE ONLYDO NOT USE ON OPEN WOUNDS, CUTS, DAMAGED OR INFECTED SKIN AS WELL AS IN THE EYES, MOUTH, GENITALS OR OTHER MUCOUS MEMBRANESTOP USE AND CONSULT YOUR PHYSICIAN IF PAIN IS PERSISTENT OR WORSENS

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Dosage & Administration

DIRECTIONS- APPLY ON CLEAN SKIN AND GENTLY RUB OVER AREA WITH PAIN. DO NOT USE MORE THAN 4 TIMES A DAY. WASH HANDS AFTER LOTION IS APPLIED AND RUBBED ONTO SKIN.

Inactive Ingredient

INACTIVE INGREDIENTSAcrylates/C10-30 Alkyl Acrylates Crosspolymer, Butterbur Extract, Cetearyl Alcohol and Polysorbate 60, Glucosamine HCl, Glyceryl Stearate and Peg 100 Stearate, Hydroxypropyl Methylcellulose, Isopropyl Palmitate, Phenoxyethanol, Ethylhexylglycerin, Pine Bark Extract, Prickly Ash Bark Extract, Propylene Glycol, Sichuan Peppercorn Extract , Stearyl Alcohol, Water Deionsed, Willowbark Extract, Wintergreen Extract

* Please review the disclaimer below.