Label: 999 ITCH RELIEF- menthol ointment

  • 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 October 22, 2013

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  • ACTIVE INGREDIENTS

    Menthol 1%

    Camphor (synthetic) 1%

    Dexamethasone Acetate 0.075%

  • Purpose

    External Analgesic

    External Analgesic

    Anti-allergic

  • For the temporary relief of pain caused by itching and rashes, poison ivy, poison oak

  • Warnings

    For external use only. Avoid contact with the eyes. If swallowed, get medical help or contact a Poison Control Center right away.

  • Stop use and seek medical advice if

    Condition worses. Symptoms persisit for more than 7 days. Symptoms clear up and occur again within a few days. Excessive irritation of the skin develops.

  • Directions

    Pregnant and children under 2 years of age. Do not use, consult a doctor.

  • Warnings

    Keep out of reach of children.

  • Directions

    Adult and children 2 years of age and older. Apply liberally to affected area not more than 5 times daily and 5-8 times per day for some severe cases or follow doctor's instruction.

  • Other Information

    Keep in a lightly closed container. Store at 8 to 30 degree centigrade (46-86 Fahrenheit) in a dry plac away from sunlight.

  • Inactive Ingredients

    Hexadecanolactone

    Ethylparaben

    Glycerin

    Glycertyl Monostearate

  • Drug Facts

    carton

  • INGREDIENTS AND APPEARANCE
    999 ITCH RELIEF 
    menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12753-930
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL200 mg  in 20000 mg
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)200 mg  in 20000 mg
    DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL) DEXAMETHASONE15 mg  in 20000 mg
    Inactive Ingredients
    Ingredient NameStrength
    HEXADECANOLACTONE (UNII: 64E2HO00C7)  
    Ethylparaben (UNII: 14255EXE39)  
    Glycerin (UNII: PDC6A3C0OX)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12753-930-1920000 mg in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/03/2003
    Labeler - China Resources Sanjiu Medical & Pharmaceutical Co Ltd (544695711)
    Registrant - China Resources Sanjiu Medical & Pharmaceutical Co Ltd (544695711)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Resources Sanjiu Medical & Pharmaceutical Co Ltd544695711manufacture(12753-930)
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