RE-LEVE (MENTHOL) GEL [SOMBRA COSMETICS INC.]

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RE-LEVE (MENTHOL) GEL [SOMBRA COSMETICS INC.]
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NDC 61577-3242-4, 61577-3242-5
Set ID b4b39d79-0439-41e7-adca-e5ccb8f44e40
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 4%

  • 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

    Keep out of reach of children.  For external use only. Avoid contact with eyes and mucous membranes, wounds or damaged skin.  Do not use with heating pads.

    Stop uses and ask a doctor if: Conditions worsen, symptoms persist for more than 7 days, symptoms clear up and occur again within a few days.

  • Directions

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

  • Inactive Ingredients

    aloe barbadensis leaf juice, carbomer, decyl glucoside, water, citrus grandis (grapefruit) seed extract, emu oil, citrus aurantium dulcis (orange) peel oil, glycerin, hamamelis virginiana (witch hazel) leaf extract, yucca schidigera root extract, sodium hydroxymethylglycinate

  • Questions or Comments?  Orders: 

    Call toll-free:  1-844-303-0037, 155 NE Court St.-152, Prineville, OR, 97754.  www.allforu.org.  Alcohol-free product made in USA.

  • PRINCIPAL DISPLAY PANEL

    LABEL

  • INGREDIENTS AND APPEARANCE
    RE-LEVE 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-3242
    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)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    WATER (UNII: 059QF0KO0R)  
    CITRUS MAXIMA SEED (UNII: 083X55C543)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)  
    ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
    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:61577-3242-4113.6 g in 1 JAR; Type 0: Not a Combination Product10/05/2016
    2NDC:61577-3242-5113.6 g in 1 TUBE; Type 0: Not a Combination Product10/05/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/05/2016
    Labeler - SOMBRA COSMETICS INC. (097464309)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOMBRA COSMETICS INC.097464309manufacture(61577-3242) , label(61577-3242)
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