Label: NOVARNICA FOOT PAIN RELIEVER- camphor and menthol spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 19, 2022

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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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