Label: WEH-WEH NATURAL PAIN RELIEF OIL- capsaicin oil

  • NDC Code(s): 35192-023-04
  • Packager: CA-BOTANA INTERNATIONAL
  • 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 7, 2021

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

  • Warning section

    For external use only.
    Do not use on wounds or damaged skin
    When using this product: use only as directed. Avoid contact with eyes. Do no bandage tightly
    Stop use and ask a doctor if: redness is present. Irritation develops. Condition worsens or symptoms persist more than 7 days. Symptoms clear up and occur again within a few days.
    Store at room temperature. Lot number and expiration date see crimp or see box.

  • OTC - Active Ingredient

    Capsaicin 0.15%

  • Purpose

    For temporary relief of minor aches and paims of muscles and joints associated with *single aches *back aches *arthritis * strains* bruises*sprains

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact a Posion Control Center immediately.

  • Inactive Ingredients

    Capri/ capri /tryglyceride, Chamomilla recutita (Chamomile) flower, Citrus bergamia (Bergamot) oil, Commiphora mukul (Guggul) Gum resin, Curcuma Xanthorrhiza,Eucaliptus globulus (Eucaliptus) oil,Humulus lupulus (Hop), Lavandula officinalis(Lavender) oil, Melaleuca alternifolia (Tea tree) oil, Pelargonium gravolens (Geranium) oil, Rosmarinus officinalis (Rosemary), Sage Triloba Fructicosa (Salvia triloba (Sage), Vitis vinifera (Grape seed)oil

  • Dosage & Administration

    External topical analgesic, massage oil to the affected area not more than 4 times daily

  • Indications & Usage

    Apply generous amont of oil directly on affected area. Massage into painful area until thoroughly absorbed into skin

  • Package label principal display

    https://direct.fda.gov/apex/apex_util.get_blob_file?a=100&s=124576570469456&p=114&d=53000640981392638&i=53003644846473016&p_pk1=17118&p_pk2=Weh-Weh Oil.jpg&p_ck=A111B4F4BD5E503D93F2F34DD4E31475

  • INGREDIENTS AND APPEARANCE
    WEH-WEH NATURAL PAIN RELIEF OIL 
    capsaicin oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35192-023
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.075 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    GUGGUL (UNII: 34969JX79R)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    CURCUMA XANTHORRHIZA OIL (UNII: F8VF0V2G7H)  
    HOPS OIL (UNII: 06JI9W529S)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
    SAGE OIL (UNII: U27K0H1H2O)  
    GRAPEFRUIT (UNII: O82C39RR8C)  
    CHAMOMILE (UNII: FGL3685T2X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    Product Characteristics
    Colorbrown (Brown -yellowish) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35192-023-0450 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product01/31/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/31/2016
    Labeler - CA-BOTANA INTERNATIONAL (106276728)
    Establishment
    NameAddressID/FEIBusiness Operations
    CA-BOTANA INTERNATIONAL106276728manufacture(35192-023)