NOVARNICA SPORT (MENTHOL) CREAM [XCENTRIK INC.]

NOVARNICA SPORT (MENTHOL) CREAM [XCENTRIK INC.]
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NDC 61871-012-15
Set ID 4c0df2b8-3967-4e9d-969b-0209a48eea31
Category HUMAN OTC DRUG LABEL
Packager Xcentrik Inc.
Generic Name
Product Class
Product Number
Application Number PART348
  • 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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