999 ITCH RELIEF (MENTHOL) OINTMENT [CHINA RESOURCES SANJIU MEDICAL & PHARMACEUTICAL CO LTD]

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999 ITCH RELIEF (MENTHOL) OINTMENT [CHINA RESOURCES SANJIU MEDICAL & PHARMACEUTICAL CO LTD]
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NDC 12753-930-19
Set ID d2390d79-4a64-4773-926b-3ebcdc0727f9
Category HUMAN OTC DRUG LABEL
Packager China Resources Sanjiu Medical & Pharmaceutical Co Ltd
Generic Name
Product Class
Product Number
Application Number PART348
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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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