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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Box floril redness relief

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

Stop use and ask doctor if

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).

FLORIL REDNESS RELIEF 
naphazoline hydrochloride solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16995-001
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE3 mg  in 10 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH) (POLYSORBATE 20 - UNII:7T1F30V5YH) POLYSORBATE 202 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
LIME (UNII: C7X2M0VVNH) 353 mg  in 10000 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16995-001-013 mL in 1 BOTTLE, DROPPER
2NDC:16995-001-0210 mL in 1 BOTTLE, DROPPER
3NDC:16995-001-0315 mL in 1 BOTTLE, DROPPER
4NDC:16995-001-0430 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34911/10/2005
Labeler - VITALINE S.A.C. (954343687)

Revised: 1/2010
Document Id: e4ff216e-e4a8-4c7e-b752-ce1621eba1b5
Set id: be1d52aa-2a40-42d6-8108-ab02bb37711b
Version: 2
Effective Time: 20100107
 
VITALINE S.A.C.