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

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NOVARNICA FOOT PAIN RELIEVER (CAMPHOR AND MENTHOL) SPRAY [XCENTRIK INC.]
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NDC 61871-005-01
Set ID 33faf91e-0ffe-499f-b190-1b7969f1231a
Category HUMAN OTC DRUG LABEL
Packager Xcentrik Inc.
Generic Name
Product Class
Product Number
Application Number PART348
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Camphor 4%
    Menthol 8%

  • Purpose

    Topical Analgesic

  • Uses

    For quick and temporary relief of foot muscle and joint pain associated with arthritis, strains and sprains or tired and aching feet, tendon and ligament pain, bruises due to a fall or blow.

  • Warnings

    Allergy Alert: Do not use if allergic to Asteraceae or Compositae (daisy) family or to any other ingredient contained in this product.

    • For external use only.
    • Discontinue use if appearance of rash, irritation, reddening, dermatitis or eczema.
    • Do not apply on wounds.
    • Avoid contact with eyes and mucous membranes.
    • Do not apply bandage or heat (heating pad) on the affected body part.
    • Consult a healthcare practitioner prior to use if you are pregnant or breastfeeding.
    • Do not inhale or swallow.

    • Keep safely out of reach of children. In case of overdose or accidental ingestion, call a poison control center immediately.
    • Flammable: Keep away from fire or flame.
  • Directions

    • Shake well before usage.
    • For adult and children 12 years and older, spray Novarnica on affected area 3-4 times daily.
    • Let penetrate through skin, no rubbing necessary.
    • If pain persists or worsens more than 7 days, discontinue use and consult a doctor.
  • Inactive ingredients

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

  • Questions or comments?

    Toll free 1-800-441-5375
    Weekdays, 9 AM to 5 PM (EST)
    info@novarnica.com

    Distributed by Xcentrik Inc.
    7902 Samuel Hatt
    Chambly (Quebec) Canada J3L 6W4
    www.novarnica.com

  • Principal Display Panel

    novarnica

    Spray Formula

    Foot Pain RELIEVER
    WITH NATURAL INGREDIENTS
    Arnica Montana

    Tired feet
    Sprains
    Strains
    Arthritis

    Pain to the:
    Heels
    Ankles
    Arches

    2.19 FL OZ (65 ml) NDC 61871-005-01
    2.19 fl oz (65 ml)

  • INGREDIENTS AND APPEARANCE
    NOVARNICA FOOT PAIN RELIEVER 
    camphor and menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61871-005
    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:61871-005-011 in 1 CARTON04/01/2015
    165 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 FINALpart34804/01/2015
    Labeler - Xcentrik Inc. (206906492)
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