Label: NUMM WARM SIZZLE- menthol camphor gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 11, 2023

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  • Active Ingredients

    Camphor 3%, Menthol 3%

  • Purpose

    Purpose External Analgesic

  • Keep out of reach of childern

    Keep out of reach of childern

  • Uses

    Temporarily relieves minor aches and pains of muscles and joints 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,camellia sinensis (green tea) leaf extract, caprylyl glycol, capsicum annuum fruit extract, carbomer, citrus aurntium dulcis (orange) peel oil, citrus grandis (grapefruit) seed extract, decyl glucoside, filipendula ulmaria flower (queen of the prairie) extract, glycerin, hamamelis virginiana (witch hazel) leaf extract, phenoxyethanol, purified water, rosa damascena flower water, sodium carbornate, yucca schidigera stem extract,

  • Question or comments

    1-800-225-3963

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    NUMM WARM SIZZLE 
    menthol camphor gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-4400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC).03 g  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL.03 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)  
    CAPSICUM (UNII: 00UK7646FG)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)  
    GRAPEFRUIT SEED OIL (UNII: 598D944HOL)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61577-4400-1226.8 g in 1 JAR; Type 0: Not a Combination Product10/11/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM10/11/2023
    Labeler - SOMBRA COSMETICS INC. (097464309)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOMBRA COSMETICS097464309manufacture(61577-4400) , label(61577-4400)
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