Label: RE-LEVE FOOTLUBE PAIN RELIEF- menthol gel

  • 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 November 28, 2022

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  • Active Ingredients

    Menthol USP 3%

  • Purpose

    Purpose
    External Analgesic

  • Keep out of the reach of children

    ​Keep out of the reach of children

  • Uses

    Detoxifies joints, relieves sore feet, athletes foot, foot odor, perspiration and coldness. Soothes and relieves pain after long hours of standing on feet.

  • Warnings

    Keep out of the reach of children. For external use only. Aviod contact with eyes and mucous membranes, wounds or damaged skin. Store at room temperature. Do not use with heating pads. If symtoms do not respond within one week, see doctor. ReLEVE Products makes no medical claims.

  • Directions

    Apply before putting on socks and shoes.

  • Inactive Ingredients

    Purified water, Carbomer, Yellow #5 Colorant, Blue #1 Colorant, Hamamelis Viriniana Leaf Extract, Yucca Schidigera Stem/Root Extract, Citrus Grandis (Grapefruit) Seed Extract, Decyl Glucoside, Vegetable Glycerin, Aloe Barbadensis Leaf Juice, Emu Oil, Simmondsia Chinensis (Jojoba) Seed oil, Phenoxyethanol, Germanium oil, Caprylyl Glycol, Sodium Carbonate.

  • Questions or Comments?

    Call Toll Free: 1-866-673-5383, 6070 S. Eastern Ave. Suite 210, Las Vegas, NV 89119, www.reskincare.com

  • label

    LABEL

  • INGREDIENTS AND APPEARANCE
    RE-LEVE FOOTLUBE PAIN RELIEF 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-5042
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.03 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    YUCCA SCHIDIGERA STEM (UNII: N59C6T6D72)  
    GRAPEFRUIT SEED OIL (UNII: 598D944HOL)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EMU OIL (UNII: 344821WD61)  
    JOJOBA OIL (UNII: 724GKU717M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61577-5042-5118 g in 1 TUBE; Type 0: Not a Combination Product11/28/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/28/2022
    Labeler - SOMBRA COSMETICS INC. (097464309)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOMBRA COSMETICS INC.097464309manufacture(61577-5042) , label(61577-5042)
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