Label: ASTRAPHARM CHILLI BRAND EXTERNAL MEDICATED- capsaicin plaster

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated June 1, 2017

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  • ACTIVE INGREDIENT

    Active ingredients
    Capsaicin 0.25%

  • PURPOSE

    Purpose
    External analgesic

  • INDICATIONS & USAGE

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

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • WARNINGS

    Warnings
    For external use only

    Allergy alert: This product contains natural rubber latex which may cause allergic reactions

  • DO NOT USE

    Do not use

    • on wounds
    • on irritated or damaged skin
  • WHEN USING

    When using this product

    • avoid contact with the eyes or mucous membranes
    • do not bandage tightly
  • STOP USE

    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 pain persists for more than 10 days
      • if redness is present
      • in conditions affecting children under 12 years of age
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Peel apart from paper backing and apply directly to the affected area. If needed, cut plaster into small pieces and apply to affected area. It will be more effective when used after a bath.
    • Adults and children 2 years and older: Apply to affected area no more than 3 to 4 times daily.
    • Children under 2 years: Do not use, consult a doctor.
  • OTHER SAFETY INFORMATION

    Other information

    • Not recommended for people with sensitive skin. May cause rash or festering.
    • Not recommended for use when in contact with hot water. Burning sensation may occur.
    • Do not apply on extremely hairy surface of skin. Highly adhesive plaster may hurt skin upon removal of product.
    • Preserve in tight container after opening.

    • Store at 20-25°C (68-77°F)

  • INACTIVE INGREDIENT

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

  • QUESTIONS

    Questions or comments? (888) 221-3496 M-F 9 am to 5 pm

    • you may also report serious side effects to this phone number
  • PRINCIPAL DISPLAY PANEL

    ASTRAPHARM CHILLI BRAND EXTERNAL MEDICATED PLASTER
    NDC 11993-001-01
    Simple backache, Arthritis, Strains, Bruises, Sprains
    1 Sheet - 4.5 in x 7 in (11.4 cm x 17.8 cm)

    1 Sheet Pouch

  • PRINCIPAL DISPLAY PANEL

    ASTRAPHARM CHILLI BRAND EXTERNAL MEDICATED PLASTER
    NDC 11993-001-02
    Simple backache, Arthritis, Strains, Bruises, Sprains
    5 Sheets - (3.4 x 4.5 in Each)

    5 Sheet Pouch

  • INGREDIENTS AND APPEARANCE
    ASTRAPHARM CHILLI BRAND EXTERNAL MEDICATED 
    capsaicin plaster
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11993-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN70 mg
    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)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11993-001-0124 in 1 BOX05/01/2007
    11 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:11993-001-0210 in 1 BOX05/01/2007
    25 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/01/2007
    Labeler - DERSAN PHARMACEUTICAL CO LTD (657669362)
    Establishment
    NameAddressID/FEIBusiness Operations
    DERSAN PHARMACEUTICAL CO LTD657669362manufacture(11993-001)