SUNMARK EYE DROPS ORIGINAL FORMULA- tetrahydrozoline hcl solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)

Available from:

Strategic Sourcing Services LLC

INN (International Name):

TETRAHYDROZOLINE HYDROCHLORIDE

Composition:

TETRAHYDROZOLINE HYDROCHLORIDE 0.05 g in 100 mL

Administration route:

OPHTHALMIC

Prescription type:

OTC DRUG

Therapeutic indications:

Redness reliever - relieves redness of the eye due to minor eye irritations

Authorization status:

OTC monograph final

Summary of Product characteristics

SUNMARK EYE DROPS ORIGINAL FORMULA- TETRAHYDROZOLINE HCL SOLUTION/
DROPS
STRATEGIC SOURCING SERVICES LLC
----------
SUNMARK EYE DROPS ORIGINAL FORMULA (PLD)
ACTIVE INGREDIENT
Tetrahydrozoline HCL 0.05%
PURPOSE
Redness reliever
USES
relieves redness of the eye due to minor eye irritations
WARNINGS
FOR EXTERNAL USE ONLY
ASK A DOCTOR BEFORE USE IF YOU HAVE
narrow angle glaucoma
WHEN USING THIS PRODUCT
pupils may become enlarged temporarily
to avoid contamination, do not touch tip of container to any surface.
Replace cap
after using
if solution changes color or becomes cloudy, do not use
overuse may produce increased redness of the eye
remove contact lens before using
STOP USE AND ASK A DOCTOR IF
you experience
eye pain
changes in vision
continued redness or irritation of the eye, or if the condition
worsens or persists for
more than 72 hours
IF PREGNANT OR BREAST-FEEDING
ask a health professional before use
KEEP OUT OF REACH OF CHLIDREN
If swallowed, get medical help or contact a Poison Control Center
right away
DIRECTIONS
Instill 1 or 2 drops in the affected eye(s) up to four times daily
OTHER INFORMATION
Store at 15 -30°C (59°-86°F)
INACTIVE INGREDIENTS
benzalkonium chloride, boric acid, edetate disodium, purified water,
sodium borate,
sodium chloride
SUNMARK EYE DROPS ORIGINAL FORMULA
tetrahydrozoline hcl solution/ drops
PRODUCT INFORMATION
Strategic Sourcing Services LLC
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:49348-037
ROUTE OF ADMINISTRATION
OPHTHALMIC
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D)
(TETRAHYDROZOLINE - UNII:S9U025Y077)
TETRAHYDROZ OLINE
HYDROCHLORIDE
0.05 g
in 100 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:49348-
03