NDC 65923-585 Family Care Arthritis Pain Relief

Capsaicin

NDC Product Code 65923-585

NDC 65923-585-14

Package Description: 1 TUBE in 1 CARTON > 14 g in 1 TUBE

NDC Product Information

Family Care Arthritis Pain Relief with NDC 65923-585 is a a human over the counter drug product labeled by United Excahnge Corp.. The generic name of Family Care Arthritis Pain Relief is capsaicin. The product's dosage form is cream and is administered via topical form.

Labeler Name: United Excahnge Corp.

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.

Family Care Arthritis 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.

  • CAPSAICIN .75 mg/g

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.

  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ALCOHOL (UNII: 3K9958V90M)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
  • SORBITOL (UNII: 506T60A25R)
  • WATER (UNII: 059QF0KO0R)

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: United Excahnge Corp.
Labeler Code: 65923
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: 07-26-2016 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.

Family Care Arthritis Pain Relief Product Label Images

Family Care Arthritis 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

Active ingredient                                                                 PurposeCapsaicin 0.075%............................................................ Topical analgesic

Otc - Purpose

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

Warnings

WarningsFor external use only.Do not apply to wounds or to damaged or irritated skin.

Otc - When Using

  • When using this productyou may experience a burning sensation which is normal and related to the way the product works. With regular use, this sensation generally disapperas within several days.avoid contact with eyes, do not get on mucous membranes, into eyes, or on contact lesnes. If this occurs, rinse the affected area throughly with water.do not apply immediately before or after activities such as bathing, swimming, sun bathing, or strenuous excercisedo not apply heat to the treated areas immediately before or after usedo not tightly wrap or bandage the treated areaavoid inhaling airborne material from dried residue. This can result in coughing, sneezing, tearing, throat or respiratory irritation.

Otc - Ask Doctor

  • Stop use and ask a doctor ifcondition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctorblistering occursdifficulty breathing or swallowing occurssevere burning persists

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Indications & Usage

  • Directionsfor persons under 18 years of age, ask a doctor before usingapply a thin film of cream and gently rub in until fully absorbedfor optimum relief, apply 3 to 4 times dailybest results typically occur after 2 to 4 weeks of continuous useunless treating hands, wash hands throughly with soap and water immediately after use

Storage And Handling

  • Other informationstore at 15° to 30°C (59° to 86°F)Lot No. & Exp. Date: see box or see crimp of tube

Inactive Ingredient

Inactive ingredientsbenzyl alcohol, cetyl alcohol, ethanol, isopropyl myristate, petrolatum, polyoxyl 40 stearate, sobritan monostearate, sorbitol solution, water

Dosage & Administration

Distributed by:United Exchange Corp.17211 Valley View Ave.Cerritos, CA 90703 U.S.A.www.ueccorp.comToll Free: 1 800 814 8028Made in Korea

* Please review the disclaimer below.