Label: HYSAN HUA TUO HUO LU (methyl salicylate, camphor- synthetic oil

  • NDC Code(s): 63255-123-01, 63255-123-02
  • Packager: HYSAN PHARMACEUTICAL CO LTD
  • 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 February 18, 2021

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  • 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

    HTHL50cc_MIC_2021

    HTHL3cc_MIC_2021

  • INGREDIENTS AND APPEARANCE
    HYSAN HUA TUO HUO LU 
    methyl salicylate, camphor (synthetic) oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63255-123
    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:63255-123-0150 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/18/2021
    2NDC:63255-123-023 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/18/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/18/2021
    Labeler - HYSAN PHARMACEUTICAL CO LTD (666427133)
    Establishment
    NameAddressID/FEIBusiness Operations
    HYSAN PHARMACEUTICAL CO LTD666427133manufacture(63255-123)
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