Label: SINOFRESH NASAL AND SINUS CARE- eucalyptus globulus leaf, potassium dichromate liquid

  • NDC Code(s): 59228-103-11
  • Packager: EMS Contract Packaging
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated April 22, 2022

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS

    EUCALYPTUS GLOBULUS 20X

    KALIUM BICHROMICUM 30X

  • PURPOSE

    PURPOSE

    ANTISEPTIC

    RELIEVES SINUS PAIN, PRESSURE AND INFLAMMATION

  • INDICATIONS & USAGE

    USES

    RELIEVES NASAL AND SINUS SYMPTOMS ASSOCIATED WITH PERSISTENT SINUS CONDITIONS:

    • CONGESTION
    • NASAL INFLAMMATION
    • SINUS PRESSURE
    • FACIAL PIN
    • SINUS HEADACHE
    • STUFFY NOSE
  • WARNINGS

    ASK A DOCTOR BEFORE USE IF YOU HAVE

    • HAD ANY MEDICAL PROCEDURES FOR YOUR NOSE OR SINUSES
    • A BLEEDING OR IRRITATED NOSE
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

    IF MORE THAN USED FOR SPRAYING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    • ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER (WITH ADULT SUPERVISION) MORNING AND EVENING, APPLY 1 TO 2 SPRAYS TO EACH NOSTRIL.

  • INACTIVE INGREDIENT

    OTHER INGREDIENTS

    BENZALKONIUM CHLORIDE, CETYLPYRIDINIUM CHLORIDE, DBASIC SODIUM PHOSPHATE, ESSENTIAL OIL BLEND (CONSISTING OF WINTERGREEN OIL, SPEARMINT OIL, PEPPERMINT OIL, AND EUCALYPTUS OIL), MONOBASIC SODIUM PHOSPHATE, POLYSORBATE 80, PROPYLENE GLYCOL, PURIFIED WATER, SODIUM CHLORIDE, AND SORBITOL SOLUTION

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    SINOFRESH  NASAL AND SINUS CARE
    eucalyptus globulus leaf, potassium dichromate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59228-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6) EUCALYPTUS GLOBULUS LEAF20 [hp_X]  in 100 mL
    POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE30 [hp_X]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SORBITOL (UNII: 506T60A25R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59228-103-1129.6 mL in 1 BOTTLE; Type 0: Not a Combination Product05/30/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/30/2014
    Labeler - EMS Contract Packaging (048602791)