Label: NOVA NATURA TOPICAL ANALGESIC- camphor, capsicum oleoresin, methyl salicylate patch

  • NDC Code(s): 84046-001-01
  • Packager: SEYITLER KIMYA SANAYI ANONIM SIRKETI
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 6, 2024

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  • Drug Facts

  • Active ingredients

    Camphor 3.3%

    Capsicum oleoresin 0.045% as capsaicin

    Methyl salicylate 10%

    Purpose

    Topical Analgesic

  • Use

    • For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.
  • Warnings

    For external use only

    When using this product

    • avoid contact with eyes or mucous membranes
    • do not apply to wounds or damaged skin
    • do not bandage tightly
    • do not use otherwise than as directed

    Stop use and ask a doctor if

    • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
    • excessive irritation of the skin develops

    Keep out of reach of children to avoid accidental poisoning.

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

  • Directions

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

    • Avoid storing product in direct sunlight
    • Protect product from excessive moisture
  • Inactive ingredients

    Butylated hydroxytoluene, lanolin, paraffinum liquidium, zinc oxide.

  • Package Labeling:

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  • INGREDIENTS AND APPEARANCE
    NOVA NATURA TOPICAL ANALGESIC 
    camphor, capsicum oleoresin, methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84046-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)72.17 mg  in 1 g
    CAPSICUM OLEORESIN (UNII: UW86K581WY) (CAPSICUM OLEORESIN - UNII:UW86K581WY) CAPSICUM OLEORESIN1.01 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE218 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    LANOLIN (UNII: 7EV65EAW6H)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84046-001-011 in 1 BOX01/02/2024
    150 in 1 PACKET
    12.187 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/02/2024
    Labeler - SEYITLER KIMYA SANAYI ANONIM SIRKETI (631427044)
    Establishment
    NameAddressID/FEIBusiness Operations
    SEYITLER KIMYA SANAYI ANONIM SIRKETI631427044manufacture(84046-001)
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