Label: NATURES WILLOW BALM- menthol cream

  • 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 January 28, 2021

If you are a consumer or patient please visit this version.

  • SPL Unclassified Section

    Drug Facts

  • Active ingredient

    Menthol 3%

  • Purpose

    External Analgesic

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with

    - arthritis

    - simple backache

    - strains

  • Warnings

    For external use only

    Do not use on wounds or damaged skin

    When using this product

    - avoid contact with eyes

    - do not bandage tightly

    ​Stop use and ask a doctor if

    - condition worsens

    - symptoms persist for more than 7 days or clear up and occur again within a few days

    If pregnant or breast-feeding, ask a health professional before use

  • Keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    Adults and children over 12 years of age: apply to affected area not more than 3 to 4 times daily.

    Children under 12 years of age: consult a physician.

  • Inactive ingredients

    Almond Oil, Camphor, Caprylyl Glycol, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Eucalyptus Oil, Geranium Oil, Glyceryl Stearate SE, Helichrysum Gymnocephalum Oil, Isopropyl Palmitate, Jojoba Seed Extract, Lavender Oil, Palmitic Acid, Phenoxyethanol, Propanediol, Sorbic Acid, Spearmint Oil, Stearic Acid, Stearyl Alcohol, Sunflower Oil, Triethanolamine, Water, White Willow Bark Extract

  • SPL Unclassified Section

    Distributed by WB Ventures, Cold Springs, KY 41076

    For more information or to report a serious adverse event contact 1-888-609-4556

  • Package Label

    Nature's Willow Balm

  • INGREDIENTS AND APPEARANCE
    NATURES WILLOW BALM 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73498-021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL30 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    SORBIC ACID (UNII: X045WJ989B)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    HELICHRYSUM GYMNOCEPHALUM WHOLE (UNII: 0369G6I64W)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
    SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73498-021-0199 g in 1 TUBE; Type 0: Not a Combination Product01/28/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/28/2021
    Labeler - WB VENTURES LLC (067482664)