Label: LEADER CAPSAICIN- capsaicin cream

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

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 March 1, 2012

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  • ACTIVE INGREDIENT

    Active ingredient                                                                      Purpose

    Capsaicin 0.1%........................................................................Topical analgesic

  • PURPOSE

    For the temporary relief of minor pain associated with:

    • Arthritis
    • Simple backache
    • Muscle strains
    • Sprains
    • Bruises
  • WARNINGS

    Warnings

    For external use only

  • WHEN USING

    When using this product

    • use only as directed
    • do not bandage
    • do not use with heating pad
    • avoid contact with eyes and mucous membranes
    • do not apply to wounds, damaged, broken or irritated skin
    • a slight burning
    • sensation may occur upon application but generally disappears in several days
    • if severe burning occurs, discontinue use
    • do not expose the treated area to heat or direct sunlight
    • do not use if allergic to capsicum or chili peppers
  • 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
    • irritation develops
  • 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.

    In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Directions

    Adults and children over 18 years:

    • apply generously to affected area not more than 3 to 4 times daily
    • massage into painful area until thoroughly absorbed
    • wash hands with soap and water after use
    • close cap tightly after use
    Children 18 years or younger: Ask a doctor
  • INACTIVE INGREDIENT

    Inactive ingredients

    Benzyl alcohol, cetyl alcohol, citric acid, glyceryl stearate SE, isopropyl myristate, PEG 100 stearate, petrolatum, purified water, sorbitol

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY CARDINAL HEALTH

    DUBLIN, OHIO 43017

    CIN 3696283

    www.myleader.com

    1-800-200-6313

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image of carton labelEnter section text here

  • INGREDIENTS AND APPEARANCE
    LEADER CAPSAICIN 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-641
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-641-131 in 1 CARTON
    142 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/01/2012
    Labeler - CARDINAL HEALTH (097537435)
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