HYSAN HUA TUO HUO LU (METHYL SALICYLATE, CAMPHOR (SYNTHETIC)) OIL [HYSAN PHARMACEUTICAL CO LTD]

HYSAN HUA TUO HUO LU (METHYL SALICYLATE, CAMPHOR (SYNTHETIC)) OIL [HYSAN PHARMACEUTICAL CO LTD]
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NDC 63255-121-01, 63255-121-02
Set ID 8ca80429-57dd-4e14-8334-cae87f55b836
Category HUMAN OTC DRUG LABEL
Packager HYSAN PHARMACEUTICAL CO LTD
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    ​Drug Facts

    Active Ingredients

    ​Methyl Salicylate 37%

    Camphor 10%

  • PURPOSE

    ​Purpose

    ​External Analgesic

  • INDICATIONS & USAGE

    ​Uses

    ​Temporarily relieves minor aches, pains of muscles and joint pains due to:

    • simple backache
    • arthritis
    • strains
    • sprains
    • bruises
  • WARNINGS

    ​warnings

    • external use only
    • use only as directed
  • DO NOT USE

    ​Do not use

    • on opened wounds
    • on damaged skin
  • WHEN USING

    ​When using this product

    • avoid contact with the eyes
    • do not bandage tighly
  • STOP USE

    ​Stop use and ask a doctor if

    • a rash or irritation develops
    • condition worsens
    • symptoms persist for more than 7 days or clears up and occur again within a few days
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    ​Directions

    • adults and children 12 years and older, clean and dry the affected area, apply and massage gently not more than 3 to 4 times daily
    • children under 12 years of age, consult a doctor before using

  • OTHER SAFETY INFORMATION

    Other information

    • be stored below 28°C (82°F)
    • closed tightly after used
  • INACTIVE INGREDIENT

    Inactive ingredients

    menthol, turpentine oil, eucalyptus oil, lavender oil, tolu balsam

  • QUESTIONS

    Question or comments?

    (626) 354 1819 M-F 9am to 5pm

  • PRINCIPAL DISPLAY PANEL

    HT_HL_50_NF_2017HT_HL_3_NF_2017

  • INGREDIENTS AND APPEARANCE
    HYSAN HUA TUO HUO LU 
    methyl salicylate, camphor (synthetic) oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63255-121
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE37 g  in 100 mL
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MENTHOL (UNII: L7T10EIP3A)  
    TURPENTINE OIL (UNII: C5H0QJ6V7F)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    TOLU BALSAM (UNII: TD2LE91MBE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63255-121-0150 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/01/2017
    2NDC:63255-121-023 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/01/2017
    Labeler - HYSAN PHARMACEUTICAL CO LTD (666427133)
    Establishment
    NameAddressID/FEIBusiness Operations
    HYSAN PHARMACEUTICAL CO LTD666427133manufacture(63255-121)

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