FAMILY CARE ARTHRITIS PAIN RELIEF (CAPSAICIN) CREAM [UNITED EXCAHNGE CORP.]

FAMILY CARE ARTHRITIS PAIN RELIEF (CAPSAICIN) CREAM [UNITED EXCAHNGE CORP.]
PDF | XML

NDC 65923-585-14
Set ID 00e44dbb-687e-442c-8785-cfcee408d8f0
Category HUMAN OTC DRUG LABEL
Packager United Excahnge Corp.
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active ingredient                                                                 Purpose

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

  • 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.

  • 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.
  • 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
  • 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

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FAMILY CARE ARTHRITIS PAIN RELIEF 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-585
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.75 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-585-141 in 1 CARTON07/26/2016
    114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/26/2016
    Labeler - United Excahnge Corp. (840130579)

Related Drugs