Label: HERBALGY- camphor menthol methyl salicylate oil

  • 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 27, 2012

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  • ACTIVE INGREDIENT

    Active Ingredients
    Methyl Salicylate 31.5%
    Menthol 16%
    Camphor 10%

  • PURPOSE

    Purpose
    External Analgesic
    External Analgesic
    External Analgesic

  • INDICATIONS & USAGE

    Uses: For the temporary relief of minor aches and pains of muscles and joints associated withsimple backache, strains, bruises and sprains.

  • WARNINGS

    Warnings: FOR EXTERNAL USE ONLY

  • DO NOT USE

    Do not use
    • Apply on wounds, irritated or damaged skin.
    • Otherwise than as directed

  • WHEN USING

    When using this product
    • Avoid contact with the eyes, mouth or mucous membranes.
    • Do not bandage tightly.
  • STOP USE

    Stop use and ask a doctor if:
    • Condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days.
    • Excessive irritation of the skin develops.
    • When using this product for arthritis: Pain persists for more than 10 days, redness is present or in conditions affecting children under 12 years of age
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, see the advise of a health professional before using this product.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children to avoid accidental poisoning. If swallowed, contact a Doctor or Poison Control Center immediately

  • DOSAGE & ADMINISTRATION

    Directions
    Adults and children2 years of age and older: Apply to affected area not more than 3-4 times daily.
    Children under 2 years of age: Do not use, consult a doctor

  • INACTIVE INGREDIENT

    Inactive Ingredients: Eucalyptus oil, Olibanum, Myrhha resins, Corydalis rhizome and Drynaria fortunei extracts

  • PRINCIPAL DISPLAY PANEL

    Package Label
    image of package label


  • INGREDIENTS AND APPEARANCE
    HERBALGY  
    camphor menthol methyl salicylate oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66897-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)10 mL  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 mL  in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE31.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    MYRRH (UNII: JC71GJ1F3L)  
    CORYDALIS YANHUSUO TUBER (UNII: 0TUP42692Z)  
    DRYNARIA FORTUNEI ROOT (UNII: 731W842X8Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66897-003-5050 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/15/2012
    Labeler - Wicsun Trading (960476174)
    Establishment
    NameAddressID/FEIBusiness Operations
    Herbalgy Pharmaceutical Limited 667293554manufacture
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