FLORIL REDNESS RELIEF- naphazoline hydrochloride solution/ drops

FLORIL REDNESS RELIEF by

Drug Labeling and Warnings

FLORIL REDNESS RELIEF by is a Otc medication manufactured, distributed, or labeled by VITALINE S.A.C.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

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

WHEN USING

• 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
  

KEEP OUT OF REACH OF CHILDREN

If swallowed get medical help or contact a Poison Control Center right away

Use

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).

INGREDIENTS AND APPEARANCE

FLORIL REDNESS RELIEF 
naphazoline hydrochloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16995-001
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV)	NAPHAZOLINE HYDROCHLORIDE	3 mg  in 10 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH) (POLYSORBATE 20 - UNII:7T1F30V5YH)	POLYSORBATE 20	2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
LIME (UNII: C7X2M0VVNH)	353 mg  in 10000 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16995-001-01	3 mL in 1 BOTTLE, DROPPER
2	NDC: 16995-001-02	10 mL in 1 BOTTLE, DROPPER
3	NDC: 16995-001-03	15 mL in 1 BOTTLE, DROPPER
4	NDC: 16995-001-04	30 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	11/10/2005

Labeler - VITALINE S.A.C. (954343687)