Family Care Arthritis Pain Relief
FDA Label NDC 65923-585

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by United Excahnge Corp. for the product Family Care Arthritis Pain Relief (NDC 65923-585). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - when using, otc - ask doctor, otc - keep out of reach of children, indications & usage, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active ingredient                                                                 Purpose

Capsaicin 0.075%............................................................ Topical analgesic

Otc - Purpose

Uses

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

Warnings

Warnings

For external use only.

Do not apply to wounds or to damaged or irritated skin.

Otc - When Using

When using this product

  • you 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 excercise
  • do not apply heat to the treated areas immediately before or after use
  • do not tightly wrap or bandage the treated area
  • avoid 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 if

  • condition 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 doctor
  • blistering occurs
  • difficulty breathing or swallowing occurs
  • severe 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

Directions

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

Storage And Handling

Other information

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

Inactive Ingredient

Inactive ingredients

benzyl 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.com

Toll Free: 1 800 814 8028

Made in Korea

Package Label.Principal Display Panel

Image Description (585)

Image Description (585)

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