Label: WEH-WEH PAIN RELIEVER GEL- menthol gel

  • NDC Code(s): 35192-020-02
  • Packager: CA-BOTANA INTERNATIONAL
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 13, 2023

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  • OTC - ACTIVE INGREDIENT

    Menthol 5% Topical Analgesic

  • Other Safety Information

    Protect this product from excessive heat and direct sun

  • OTC - ASK DOCTOR

    Stop use and ask a doctor if redness is present.irritation develops. conditions worsens or symtoms persist more than 7 days. symtoms clear up and occur again within a few days

  • OTC - PURPOSE SECTION

    Uses: for temporary relief of minor aches and pains of muscles and joints associated with. simple aches. back aches. arthritis.strains.bruises.sprains.

  • Keep out of reach of children

    Keep out of reach of children

  • INACTIVE INGREDIENTS

    Aesculus hippocastanum (Horse Chestnut), Aloe barbadensis miller, Aloe barbadensis miller (Aloe Vera), Amonium Acrylcydimethyltaurate/VPCcopolymer, Arnica montana (Arnica), Bromelain, Butylene Glycol, Capsicum annum (Capsicum), Chamaemelum nobile (Chamomile), Ethyl alcohol, Eucalyptus globules (Eucaliptus) oil, FD&C Green # 3, Glucosamine Sulfate, Harpagophytum procumbens (Devil’s Claw), Melissa officinalis (Lemon Balm), Methyl Sulfonyl Methane (MSM), Polysorbate-60, Potassium Sorbate, Purified Water, Rosmarinus officinalis (Rosemary), Salix alba (Willow Bark), Edetic Acid, Tilia cordata (Linden), Xanthan Gum

  • Warnings

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

  • Dosage & Admnistration

    External topical analgesic Topical massage gel no more than 4 times daily

  • Indications & usage

    Apply generous amount of gel directly affected area massage into painful area until thoroughly absorbed into skin

  • Package label princip[al panel

    https://direct.fda.gov/apex/apex_util.get_blob_file?a=100&s=14075775173179&p=114&d=53000640981392638&i=53003644846473016&p_pk1=18134&p_pk2=865-Weh-Weh-Gel.jpg&p_ck=DD4DEEF6923E319E9AB8559D94E333E3

  • INGREDIENTS AND APPEARANCE
    WEH-WEH PAIN RELIEVER GEL 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35192-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL6 g  in 120 g
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    BROMELAINS (UNII: U182GP2CF3)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAPSICUM (UNII: 00UK7646FG)  
    TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    MELISSA OFFICINALIS (UNII: YF70189L0N)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    WATER (UNII: 059QF0KO0R)  
    ROSEMARY (UNII: IJ67X351P9)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    ALCOHOL (UNII: 3K9958V90M)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorMENTHOLImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35192-020-02120 g in 1 TUBE; Type 0: Not a Combination Product01/31/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/31/2016
    Labeler - CA-BOTANA INTERNATIONAL (106276728)
    Establishment
    NameAddressID/FEIBusiness Operations
    CA-BOTANA INTERNATIONAL106276728manufacture(35192-020)
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