Label: THERAPLUS PLUS- menthol ointment

  • NDC Code(s): 55621-004-01
  • Packager: Zhejiang Jingwei Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 24, 2023

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  • INACTIVE INGREDIENT

       carbomer, laureth-23, methylparaben, mineral oil, propylene glycol, propylparaben, stearamidoethyl diethylamine, stearic acid, stearyl alcohol, triethanomoline, water Inactive Ingredients

  • ACTIVE INGREDIENT

    Active Ingredient

    Menthol 10%

    Menthol salicylate 15%

  • WARNINGS

    Warnings

    For external use only.

    Do not use

    -on wounds or damaged skin -with a heating pad   - on a child under 12 years of age with arthritis-like condition

    When using this product

    -avoid contact with eyes and mucous membranes      -do not bandage tightly

  • PURPOSE

    Purpose

    Topical analgesic

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

      temporarily relieves minor aches and pains of muscles and joints associated with: Uses

    -simple backache   -arthritis   -bruises   -strains   -sprains

  • DOSAGE & ADMINISTRATION

    Directions

    -adults and children 12 years of age and older:  apply to all affected area not more than 3 to 4 times daily

    -children under 12 years of age: ask a doctor

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    THERAPLUS   PLUS
    menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55621-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
    MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD) (SALICYLIC ACID - UNII:O414PZ4LPZ) MENTHYL SALICYLATE, (+/-)-15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LAURETH-23 (UNII: N72LMW566G)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55621-004-0128 g in 1 TUBE; Type 0: Not a Combination Product03/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/01/2013
    Labeler - Zhejiang Jingwei Pharmaceutical Co., Ltd. (530876549)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Jingwei Pharmaceutical Co., Ltd.530876549manufacture(55621-004)
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