Label: CAPZASIN HP ARTHRITIS PAIN RELIEF- capsaicin cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 01/10

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Capzasin HP Arthritis Pain Relief

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  • Active Ingredient

    Capsaicin 0.1%

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  • Purpose

    Topical analgesic

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  • Uses

    temporarily relieves minor pain of muscles and joints associated with:

    • arthritis
    • simple backache
    • strains
    • sprains
    • bruises
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  • Warnings

    For external use only

    When using this product

    • use only as directed
    • do not bandage tightly or use with a heating pad
    • avoid contact with eyes and mucous membranes
    • do not apply to wounds, damaged, broken or irritated skin
    • a transient burning sensation may occur upon application but generally disappears in several days
    • if severe burning sensation occurs, discontinue use immediately and read important information printed inside carton
    • do not expose the area treated with product to heat or direct sunlight

    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
    • irritation develops

    If pregnant or breast-feeding

    ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    adults and children over 18 years:

    • apply to affected area
    • massage into painful area until thoroughly absorbed
    • repeat as necessary, but no more than 3 to 4 times daily
    • WASH HANDS WITH SOAP AND WATER AFTER APPLYING

    children 18 years or younger: ask a doctor

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  • Inactive Ingredients

    benzyl alcohol, cetyl alcohol, glyceryl stearate, isopropyl myristate, PEG-40 stearate, petrolatum, sorbitol, water (238-10)

    READ INFORMATION PRINTED INSIDE CARTON BEFORE USING.

    KEEP CARTON AS IT CONTAINS IMPORTANT INFORMATION.             Recyclable Carton

    Dist. by Chattem, Inc., P.O. Box 2219
    Chattanooga, TN 37409-0219 U.S.A.
    © 2009 www.chattem.com

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  • Principal Display Panel

    Deep Penetrating       Odor Free      
    HIGH POTENCY
    CAPZASIN HP®
    ARTHRITIS PAIN RELIEF

    CAPSA
    ICIN 0.1% TOPICAL             ANALGESIC CREME              Net wt 1.5 oz (42.5 g)

    Principal Display Panel - Net wt 1.5 oz (42.5 g)

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  • INGREDIENTS AND APPEARANCE
    CAPZASIN HP ARTHRITIS PAIN RELIEF 
    capsaicin cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41167-7514
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAPSAICIN (CAPSAICIN) CAPSAICIN 0.001 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BENZYL ALCOHOL  
    CETYL ALCOHOL  
    GLYCERYL MONOSTEARATE  
    ISOPROPYL MYRISTATE  
    PETROLATUM  
    SORBITOL  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41167-7514-2 1 in 1 CARTON
    1 42.5 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 12/01/1998
    Labeler - Chattem, Inc. (003336013)
    Establishment
    Name Address ID/FEI Business Operations
    Chattem Plant 1 003336013 ANALYSIS, LABEL, MANUFACTURE, PACK, RECOVERY, RELABEL, REPACK
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