Label: TE-FU RECOVERY MASSAGE- menthol, methyl salicylate lotion

  • NDC Code(s): 44717-539-01
  • Packager: Wasatch Product Development
  • 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, 2018

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

  • ACTIVE INGREDIENT

    Active ingredient Purpose

    Menthol (5.0%) Topical Analgesic

    Methyl Salicylicate (10%) Topical Analgesic

  • PURPOSE

    Uses

    Provides warming, penetrating pain relief for sore muscles and joints

    May also provide temporary relief of minor aches and pains associated with backache, strains and bruises

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of product and consult a physician.

  • WARNINGS

    Warnings

    For external use only.

    Avoid contact with eyes

    Do not bandage tightly

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 2 year of age and older apply to affected area not more than 3 to 4 times per day

    Children under 2yrs of age consult a physician.

  • INACTIVE INGREDIENT

    Inactive ingredients: Water, Cinnamomium Camphora (Camphor) Bark Oil, Stearyl Alcohol, C13-15 Alkane, Glycerin, Caprylic/capric Triglyceride, Pentylene Glycol, Glyceryl Stearate, Cetearyl Alcohol, Eucalyptus Globulus Leaf Oil, Prunus Amygdalus Dulcis( sweet almond) Oil, Microcrystalline Cellulose, Mentha Piperita (peppermint) Oil, Behenyl Alcohol, Stearyl Phosphate, Eugenia Caryophyllus (Clove) Leaf Oil, Hydroxyacetophenone, Zingiber Officinale (ginger) Root Oil, Arnica Montana Flower Extract, Benzyl Alcohol, Cellulose Gum, Cyamopsis Tetragonoloba (Guar) Gum, Xanthan Gum, Sodium Phytate.

  • PRINCIPAL DISPLAY PANEL

    Tei-Fu

    Recovery Massage Lotion

    Penetrating Muscle and Joint Relief

    4fl. oz. ( 118 mL)

    box

  • INGREDIENTS AND APPEARANCE
    TE-FU RECOVERY MASSAGE 
    menthol, methyl salicylate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44717-539
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    STEARYL PHOSPHATE (UNII: F3C8G3904Y)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    GUAR GUM (UNII: E89I1637KE)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CAMPHOR OIL (UNII: 75IZZ8Y727)  
    CLOVE LEAF OIL (UNII: VCA5491KVF)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    C13-15 ALKANE (UNII: 114P5I43UJ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    GINGER OIL (UNII: SAS9Z1SVUK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44717-539-01118 mL in 1 BOTTLE; Type 0: Not a Combination Product11/28/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/28/2018
    Labeler - Wasatch Product Development (962452533)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wasatch Product Development962452533manufacture(44717-539)