Label: NOVARNICA SPORT- menthol cream

  • 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

    Menthol 3%

  • Purpose

    Topical Analgesic

  • Uses

    For fast and soothing relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

  • 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 breast-feeding.
    • 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.
  • Directions

    • For adults and children 12 years and older, apply generously and rub on affected area until the cream has penetrated through the skin.
    • Repeat as needed up to 4 times daily.
    • If pain persists or worsens more than seven days, discontinue use and consult a doctor.
  • Inactive ingredients

    Aloe barbadensis leaf extract, arnica montana flower extract, camphor, carbomer, glycerin, isopropyl alcohol, mineral oil, peppermint essential oil, steareth-2, steareth-100, stearyl alcohol, triethanolamine, water.

  • Questions or comments?

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

    Distributed by Xcentrik Inc.
    Plattsburgh, NY, 12903
    © 2017 Xcentrik Inc.
    www.novarnica.com

  • Principal Display Panel

    novarnica sport

    Pain Relieving
    Cream
    With natural ingredients

    Special formula
    for deep penetrating
    relief of:

    Sports injuries
    Sore muscles
    Sprains/Strains

    113g (4OZ.) NDC 61871-012-15

    4 oz (113 g) NDC 61871-012-15

  • INGREDIENTS AND APPEARANCE
    NOVARNICA SPORT 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61871-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-100 (UNII: 4OH5W9UM87)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61871-012-151 in 1 CARTON03/01/2019
    1113 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34803/01/2019
    Labeler - Xcentrik Inc. (206906492)
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