NOVARNICA (CAMPHOR AND MENTHOL) SPRAY [XCENTRIK INC.]

NOVARNICA (CAMPHOR AND MENTHOL) SPRAY [XCENTRIK INC.]
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NDC 61871-001-01, 61871-001-02
Set ID 1944f4f0-1ff0-4421-8a54-7fd280588d2a
Category HUMAN OTC DRUG LABEL
Packager Xcentrik Inc.
Generic Name
Product Class
Product Number
Application Number PART348
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Camphor 4%
    Menthol 8%

  • Purpose

    Topical Analgesic

  • Uses

    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
    • Avoid contact with eyes and mucous membranes
    • Do not apply on wounds or damaged skin
    • Do not bandage tightly
    • Do not apply external heat such as an electric heating pad, as this may result in excessive skin irritation or skin burn
    • Do not apply on or near the nipple
    • If pregnant or breastfeeding, ask a health professional before use
    • Do not inhale or swallow
    • Allergy Alert: Do not use if allergic to Asteraceae/Compositae/Daisy family or to any other ingredient contained in this product
    • Flammable: Keep away from fire or flame
    • When using this product Rashes and/or burning discomfort have been known to occur; in which case discontinue use. 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.

    • Keep safely out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
  • Directions

    • Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily.
    • Children under 12 years of age: consult a physician.
  • Other information

    • Shake well before usage
    • Simply spray solution on affected body part and let penetrate through skin, no rubbing necessary
    • Storage information: Store at room temperature;
    • Close cap tightly after use
  • Inactive ingredients

    Arnica Montana flower extract, clove essential oil, eucalyptus essential oil, isopropyl alcohol, peppermint essential oil, polysorbate 20, purified water

  • Questions?

    If you have questions of a medical nature, please contact your pharmacist, doctor or health care professional

    Xcentrik Inc.
    7902 Samuel Hatt
    Chambly (Quebec) Canada J3L 6W4
    1-800-441-5375
    www.novarnica.com
    Made in Canada

  • Principal Display Panel

    novarnica

    Pain Relieving Spray
    With natural ingredients

    Simple
    Backache
    Arthritis
    Strains
    Bruises
    Sprains

    Spray solution
    No rubbing
    Fast acting

    2.19 FL OZ (65 ml)
    2.19 fl oz (65 ml)

  • PRINCIPAL DISPLAY PANEL

    4.06 FL OZ (120 ml)
    4.06 fl oz (120 ml)

  • INGREDIENTS AND APPEARANCE
    NOVARNICA 
    camphor and menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61871-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)4 g  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL8 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CLOVE OIL (UNII: 578389D6D0)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61871-001-011 in 1 CARTON01/22/2014
    165 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:61871-001-021 in 1 CARTON01/22/2014
    2120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34801/22/2014
    Labeler - Xcentrik Inc. (206906492)

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