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

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 14, 2020

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 not finalpart34803/01/2020
    Labeler - Dersan Pharmaceutical Co., Ltd (657669362)