KAPSIN EXTERNAL ANALGESIC (CAMPHOR, CAPSAICIN) OINTMENT [BEE RIGHT LLC]

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KAPSIN EXTERNAL ANALGESIC (CAMPHOR, CAPSAICIN) OINTMENT [BEE RIGHT LLC]
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NDC 71952-020-00
Set ID 4252775e-c289-432d-84ad-51c0ccc215d0
Category HUMAN OTC DRUG LABEL
Packager Bee Right LLC
Generic Name
Product Class
Product Number
Application Number PART348
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  • Drug Facts

  • Active Ingredient

    Camphor 3.16%

    Capsaicin 0.03%

    Purpose

    External Analgesic

  • Uses

    • for temporary relief of minor aches and pains of muscles and joints associated with simple backache, strains, bruises and sprains
  • Warnings

    For external use only.

    When using this product

    avoid contact with eyes.

    Do not

    apply to wounds or damaged skin.

    Do not bandage tightly.

    Stop use and consult a doctor if:

    • condition worsens or if symptoms persist for more than 7 days
    • if conditions clear up and occur again within a few days

    Keep out of reach of children.

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

  • Directions

    • Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
    • Children under 2 years of age: consult a doctor
  • Other information

    • store at 77°F (25°C)
  • Inactive ingredients

    alcohol, capsicum frutescens fruit extract, lanolin wax, petrolatum, propolis wax, waterright away.

  • Package Labeling:

    Outer Package2Inner Package2

  • INGREDIENTS AND APPEARANCE
    KAPSIN EXTERNAL ANALGESIC 
    camphor, capsaicin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71952-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)3.16 g  in 100 g
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.03 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71952-020-001 in 1 BOX07/01/2018
    160 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 finalpart34807/01/2018
    Labeler - Bee Right LLC (080988303)
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