Label: AVON HEXASHIELD ARTHRITIS PAIN RELIEF CREAM CAPSAISIN- capsaisin cream

  • NDC Code(s): 43136-101-01
  • Packager: Tai Guk Pharm. Co., Ltd.
  • 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 July 31, 2019

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  • Active Ingredient

    Capsaicin 0.075 %

  • Purpose

    Topical analgesic

  • Uses

    for temporary relieves of minor aches and pains of muscles and joints associated with:

    • arthritis
    • simple backache
    • bruises
  • Warnings

    For external use only.

    When using this product

    • use only as directed
    • do not apply to wounds, damaged, broken or irritated skin
    • avoid contact with the eyes or mucous membranes
    • 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 banage
    • do not use with heating pad

    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

    Keep out of reach of children.

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

  • 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
  • Other information

    • store at room temperature
    • Lot No. & Exp. Date: see box or see crimp of tube
  • Inactive Ingredients

    benzyl alcohol, cetyl alcohol, ethanol, isopropyl myristate, petrolatum, polyoxyl 40 stearate, orbitan monostearate, sorbitol, water

  • Questions or comments?

    Call toll free 1-800-FOR-AVON

    www.avon.com

  • Principal Display Panel

    Strong & Effective Pain Relief

    Arthritis Pain Relief

    High Potency

    AVON

    Temporary relief of pain associated with:

    • sprains
    • pains of muscles and joints
    • arthritis
    • strains

    HeXashield

    ARTHRITIS PAIN RELIEF CREAM

    CAPSAICIN

    Add 0.075%

    Deep Penetratng & Odor Free

    ARTHRITIS PAIN RELIEF

    Topical Analgesic Cream

    NET WT 1.5 oz (43.5 g)

    capsaicin

    capsaicin df

  • INGREDIENTS AND APPEARANCE
    AVON HEXASHIELD ARTHRITIS PAIN RELIEF  CREAM CAPSAISIN
    capsaisin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43136-101
    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
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ALCOHOL (UNII: 3K9958V90M)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43136-101-011 in 1 CARTON07/31/2019
    142.5 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 finalpart34807/31/2019
    Labeler - Tai Guk Pharm. Co., Ltd. (689060246)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tai Guk Pharma. Co., Ltd.689060246manufacture(43136-101)
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