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

SINOFRESH by

Drug Labeling and Warnings

SINOFRESH by is a Homeopathic medication manufactured, distributed, or labeled by EMS Contract Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59228-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6)	EUCALYPTUS GLOBULUS LEAF	20 [hp_X]  in 100 mL
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V)	POTASSIUM DICHROMATE	30 [hp_X]  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59228-103-11	29.6 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/30/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/30/2014

Labeler - EMS Contract Packaging (048602791)

Establishment
Name	Address	ID/FEI	Business Operations
EMS Contract Packaging		048602791	manufacture(59228-103)