Label: ASTRAPHARM CHILLI BRAND- capsaicin plaster

  • NDC Code(s): 11993-000-01, 11993-000-02, 11993-000-11, 11993-000-12
  • Packager: Dersan Pharmaceutical Co., Ltd
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 31, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredients

    Capsaicin 0.25%..............................External analgesic

  • ASK DOCTOR

    Stop use and ask doctor if

  • Keep out of reach of children

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

  • Directions:

    • Clean and dry affected area, peel plaster away from paper backing and apply to the affected area by pressing edges down firmly.
    • If needed, cut plaster into smaller pieces.
    • Adults and children 12 years of age and over: Apply to affected area not more than 3 times daily. Children under 12 years, consult doctor before use.
  • Other information:

    • Once opened, keep the unused plaster in an air-tight container.
    • Store at 20-25°C(68-77°F)
  • Inactive ingredients:

    Beta-pinene homopolymer, calcium carbonate, light steam-cracked aromatic naphtha(petroleum), polybutenes, rubber(natural), synthetic iron oxide, and zinc oxide

  • Questions or comments?

    M-F, 9 am to 5 pm Pacific Time

    • You may also report serious side effects to this phone number.

  • Purpose

    External analgesic

  • Do not use

    • on wounds
    • damaged or irritated skin
  • When using this product

    • avoid contact with the eyes or mucous membranes
    • do not bandage tightly
    • may cause rash or festering. Not recommended for people with sensitive skin.
    • burning sensation may occur. Not recommended for use when in contact with hot water.
    • highly adhesive plaster may hurt skin upon removal of product. Do not apply on hairy surface of skin.
  • Stop use and ask a doctor if

    • Excessive irritation of the skin develops
    • Condition worsens
    • Symptoms persist for more than 7 days
    • Symptoms clear up and occur again within a few days
    • When using for pain of arthritis:
    •    if redness is present
    •    in conditions affecting children under 12 years of age  

  • Uses:

    Temporarily relieves minor aches and pains of muscles and joints due to:

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

    For external use only

  • Astrapharm "Chilli Brand" External Analgesic Plaster 4.5in x 7in

    1.jpg

    Astrapharm Chilli Brand PDP

    Inner Package 4.5in x 7in

    2.jpg

    Inner Package

    Astrapharm "Chilli Brand" External Analgesic Plaster 4.5in x 3.4in

    3.jpg

    Astrapharm Chilli Brand PDP

    Inner Package 4.5in x 3.5in

    4.jpg

    image description

  • INGREDIENTS AND APPEARANCE
    ASTRAPHARM CHILLI BRAND 
    capsaicin plaster
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11993-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    .BETA.-PINENE (UNII: 4MS8VHZ1HJ)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    NAPHTHA (UNII: O3L624621X)  
    POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11993-000-0124 in 1 PACKAGE03/01/2020
    1NDC:11993-000-110.25 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:11993-000-0250 in 1 PACKAGE03/01/2020
    2NDC:11993-000-125 in 1 PACKAGE
    20.25 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/01/2020
    Labeler - Dersan Pharmaceutical Co., Ltd (657669362)