Label: SOMBRA COOL THERAPY- menthol gel

  • NDC Code(s): 61577-4030-1, 61577-4030-2, 61577-4030-3, 61577-4030-4, view more
    61577-4030-5, 61577-4030-6
  • 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 March 3, 2023

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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: arthritis, simple backaches

  • 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, Glycerin, Hamamelis Virginiana (Witch Hazel) Leaf
    Extract, Phenoxyethanol, Purified Water, Rosa Damascena Flower Water, Sodium Carbonate,
    Spiraea Ulmaria Flower (Queen of the Prairie) Extract, Yucca Schidigera Root Extract.

  • Questions or Comments

    1-800-225-3963

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SOMBRA COOL THERAPY 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-4030
    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)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61577-4030-13628.7 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/03/2023
    2NDC:61577-4030-65 g in 1 POUCH; Type 0: Not a Combination Product03/03/2023
    3NDC:61577-4030-2907.2 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/03/2023
    4NDC:61577-4030-3226.8 g in 1 JAR; Type 0: Not a Combination Product03/03/2023
    5NDC:61577-4030-4113.4 g in 1 JAR; Type 0: Not a Combination Product03/03/2023
    6NDC:61577-4030-585 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/03/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/03/2023
    Labeler - SOMBRA COSMETICS INC. (097464309)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOMBRA COSMETICS INC.097464309manufacture(61577-4030) , label(61577-4030)
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