QC ARTHRITIS PAIN RELIEF (CAPSAICIN) LIQUID [CHAIN DRUG MARKETING ASSOCIATION INC.]

QC ARTHRITIS PAIN RELIEF (CAPSAICIN) LIQUID [CHAIN DRUG MARKETING ASSOCIATION INC.]
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NDC 63868-203-40
Set ID 7a0987e5-419b-6e9e-e053-2991aa0a2f60
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Marketing Association Inc.
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active ingredient Purpose

    Capsaicin 0.15%...........................................................................Topical analgesic

  • PURPOSE

    Uses

    temporarily relieves minor pain of muscles and joints associated with:

    • arthritis
    • simple backache
    • strains
    • sprains
    • bruises
  • WARNINGS

    Warnings

    For external use only

    Flammable. Keep away from fire or flame.

    Allergy alert: Do not use if you are allergic to capsicum, chili peppers, or any ingredients in this product.

  • DO NOT USE

    Do not use

    • on wounds or damaged, irritated skin
    • with a heating pad
  • WHEN USING

    When using this product

    • avoid contact with the eyes, mucous membranes or rashes
    • do not bandage tightly or cover treated area
    • discontinue use at least 1 hour before a bath or shower
    • do not use immediately after a bath or shower
  • STOP USE

    Stop use and ask a doctor if

    • condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days
    • redness is present or irritation or rash develops
    • a severe burning sensation occurs
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • INDICATIONS & USAGE

    Directions

    • adults and children 18 years of age and older:
    • use only as directed
    • clean and dry affected area
    • place applicator on skin, press firmly and hold to activate the dispensing of liquid
    • massage into painful area until thoroughly absorbed
    • repeat as necessary, but no more than 3 to 4 times daily
    • IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER
    • children under 18 years of age: ask a doctor
  • STORAGE AND HANDLING

    Other information

    • store at room temperature 20-25°C (68-77°F)
    • protect from extreme heat
  • INACTIVE INGREDIENT

    Inactive ingredients

    alcohol, carbomer 940, glycerin, propylene glycol, purified water

  • DOSAGE & ADMINISTRATION

    Distributed by C.D.M.A., Inc.

    43157 W 9 Mile Rd

    Novi, MI 48375

    www.qualitychoice.com

    Made in China

  • PRINCIPAL DISPLAY PANEL

    99720

  • INGREDIENTS AND APPEARANCE
    QC ARTHRITIS PAIN RELIEF 
    capsaicin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-203
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.0015 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-203-401 in 1 BOX11/06/2018
    140 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/06/2018
    Labeler - Chain Drug Marketing Association Inc. (011920774)

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