FLORIL REDNESS RELIEF- naphazoline hydrochloride solution/ drops

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV), POLYSORBATE 20 (UNII: 7T1F30V5YH) (POLYSORBATE 20 - UNII:7T1F30V5YH)

Dostupno od:

VITALINE S.A.C.

Administracija rute:

OPHTHALMIC

Tip recepta:

OTC DRUG

Terapijske indikacije:

Naphazoline Hydrocloride 0,03% redness reliever Polysorbate 20 0,24% Lubricant - you feel eye pain - changes in vision occur - redness or irritation of the eye lasts - condition worsens or lasts more than 72 hours Relieves redness of the eye due to minor eye irritations

Status autorizacije:

OTC monograph final

Svojstava lijeka

FLORIL REDNESS RELIEF - NAPHAZOLINE HYDROCHLORIDE SOLUTION/ DROPS
VITALINE S.A.C.
_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._
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ACTIVES INGREDIENTS PURPOSE
Naphazoline Hydrocloride 0,03% redness reliever
Polysorbate 20 0,24% Lubricant
INACTIVE INGREDIENTS
Benzalkonium chloride, chamomile, dibasic sodium phosphate, edetate
disodium, monobasic sodium
phosphate, purified water.
WARNINGS
For external use only
Ask a doctor before use if you have narrow angle glaucoma
Do not use if the solution changes color or becomes cloudy
do not touch the tip of the container to any surface to avoid
contamination
replace cap after each use
overuse may cause more eye redness
pupils may become enlarged temporarily
remove contact lenses before using
STOP USE AND ASK DOCTOR IF
you feel eye pain
changes in vision occur
redness or irritation of the eye lasts
condition worsens or lasts more than 72 hours
If swallowed get medical help or contact a Poison Control Center right
away
US E
Relieves redness of the eye due to minor eye irritations
DIRECTIONS
Put 1 to 2 drops in the affected eye(s) up to 4 times daily.
OTHER INFORMATION
Store at room temperature 15° to 30° (59° to 86° F).
FLORIL REDNESS RELIEF
naphazoline hydrochloride solution/ drops
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:16 9 9 5-0 0 1
ROUTE OF ADMINISTRATION
OPHTHALMIC
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
NAPHAZO LINE HYDRO CHLO RIDE (UNII: MZ113178 7D) (NAPHAZOLINE -
UNII:H231GF11BV)
NAPHAZOLINE
HYDROCHLORIDE
3 mg
in 10 mL
PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH) (POLYSORBATE 20 - UNII:7T1F30
V5YH)
POLYSORBATE 20
2 mg in 1 mL
VITALINE S.A.C.
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
LIME (UNII: C7X2M0 VVNH)
353 mg in 10 0 0 0 mL
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:16 9 9 5-0