NVCARE (MENTHOL) GEL [SOMBRA COSMETICS INC.]

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NVCARE (MENTHOL) GEL [SOMBRA COSMETICS INC.]
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NDC 61577-5320-1
Set ID 8c78f6d0-2101-41dc-a83e-b7a3b77ac0e6
Category HUMAN OTC DRUG LABEL
Packager SOMBRA COSMETICS INC.
Generic Name
Product Class
Product Number
Application Number PART348
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  • Active Ingredients

    Menthol USP 6%

  • Purpose

    Purpose
    External Analgesic

  • Keep out of reach of children

    Keep out of reach of children

  • Uses

    Temporarily relieves minor aches and pains of muscles and joints associated with: simple backaches, strains, bruises, and sprains

  • Warnings

    For external use only. Do not use on wounds or damaged skin. When using this product: avoid bandaging tightly, avoid contact with eyes, keep out of reach of children.

    Stop use and ask doctor if: condition worsens, symptoms persist for more than 7 days, clear up and occur again within a few days.

  • Directions

    adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub in thoroughly until gel is absorbed, children under 2 years of age: consult a doctor.

  • Inactive Ingredients

    aloe barbadensis leaf juice, carbomer, decyl glucoside, water, citrus grandis (grapefruit) seed extract, camellia sinensis (green tea) leaf extract, citrus limon (lemon) peel oil, spiraea ulmaria flower (queen of the prairie) extract, rosa damascena flower water, sodium carbonate, glycerin, hamamelis virginiana (witch hazel) leaf extract, yucca schidigera root extract, phenoxyethanol, caprylyl glycol

  • Questions or Comments

    1-800-225-3963

  • PRINCIPAL DISPLAY PANEL

    LABEL

  • INGREDIENTS AND APPEARANCE
    NVCARE 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-5320
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.06 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    WATER (UNII: 059QF0KO0R)  
    GRAPEFRUIT SEED OIL (UNII: 598D944HOL)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)  
    ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)  
    LEMON OIL (UNII: I9GRO824LL)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61577-5320-1226.8 g in 1 JAR; Type 0: Not a Combination Product05/15/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/15/2018
    Labeler - SOMBRA COSMETICS INC. (097464309)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOMBRA COSMETICS INC.097464309manufacture(61577-5320) , label(61577-5320)
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