FAMILY WELLNESS ADVANCED EYE- dextran 70, polyethylene glycol 400, povidone, and tetrahydrozoline hydrochloride solution/ drops

Family Wellness Advanced Eye by

Drug Labeling and Warnings

Family Wellness Advanced Eye by is a Otc medication manufactured, distributed, or labeled by FAMILY DOLLAR. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients Purpose

Dextran 70 0.1%..........................................................Eye Lubricant

Polyethylene Glycol 400 1% .......................................Eye Lubricant

Povidone 1% ..............................................................Eye Lubricant

Tetrahydrozoline HCL 0.05% ......................................Eye Redness reliever

PURPOSE

Uses

• for the relief of redness of the eyes due to minor eye irritations
• for protection again further irritation or to relieve dryness of the eye

WARNINGS

Ask a doctor before use if you have narrow angle glaucoma

WHEN USING

When using this product

• pupils may become enlarged temporarily
• overuse may cause more eye redness
• remove contact lenses before using
• do not use if this solution changes color or becomes cloudy
• to avoid contamination, do not touch tip of container to any surface
• replace cap after each use

STOP USE

Stop use and ask a doctor if

• you feel eye pain
• changes in vision occur
• redness or irritation of the eye persists
• condition worsens or lasts more than 72 hours

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately

INDICATIONS & USAGE

Directions

• to open bottle, push cap down and twist counterclockwise
• put 1 to 2 dorps in the affected eye(s) up to 4 times daily
• children under 6 years of age: ask a doctor

STORAGE AND HANDLING

Other information

• store at 15 o to 25 oC (59 o to 77 oF)

INACTIVE INGREDIENT

Inactive ingredients: benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate and sodium chloride

DOSAGE & ADMINISTRATION

DISTRIBUTED BY:

MIDWOOD BRANDS, LLC

10611 MONROE RD.

MATTHEWS, NC 28105 USA

MADE IN SOUTH KOREA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS ADVANCED EYE 
dextran 70, polyethylene glycol 400, povidone, and tetrahydrozoline hydrochloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-322
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68)	DEXTRAN 70	1 mg  in 1 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	10 mg  in 1 mL
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E)	POVIDONE	10 mg  in 1 mL
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BORATE (UNII: 91MBZ8H3QO)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-322-15	1 in 1 CARTON	05/19/2014
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	05/19/2014

Labeler - FAMILY DOLLAR (024472631)