Label: SOMBRA COOL THERAPY- menthol gel

  • NDC Code(s): 61577-3221-1, 61577-3221-2, 61577-3221-3, 61577-3221-4, view more
    61577-3221-6, 61577-3221-7, 61577-3221-9
  • Packager: SOMBRA COSMETICS INC.
  • 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 May 17, 2022

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  • Active Ingredients

    Menthol USP 6%

  • 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 carbomer, citrus grandis (grapefruit) seed extract, citrus limon (lemon) peel oil, 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

    label

  • INGREDIENTS AND APPEARANCE
    SOMBRA COOL THERAPY 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-3221
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL.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:61577-3221-13628.7 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/17/2022
    2NDC:61577-3221-2907.2 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/17/2022
    3NDC:61577-3221-3226.8 g in 1 JAR; Type 0: Not a Combination Product05/17/2022
    4NDC:61577-3221-4113.4 g in 1 JAR; Type 0: Not a Combination Product05/17/2022
    5NDC:61577-3221-6113.4 g in 1 TUBE; Type 0: Not a Combination Product05/17/2022
    6NDC:61577-3221-756.7 g in 1 JAR; Type 0: Not a Combination Product05/17/2022
    7NDC:61577-3221-95 g in 1 POUCH; Type 0: Not a Combination Product05/17/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/17/2022
    Labeler - SOMBRA COSMETICS INC. (097464309)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOMBRA COSMETICS INC.097464309manufacture(61577-3221) , label(61577-3221)
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