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

Family Care Advanced Formula Eye by

Drug Labeling and Warnings

Family Care Advanced Formula Eye by is a Otc medication manufactured, distributed, or labeled by United Exchange Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                                                            Purpose

Tetrahydrozoline HCl 0.05%.............................................................Redness reliever

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

Polyethylene glycol 400 1%.............................................................Lubricant

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

PURPOSE

Uses

• for the relief of redness of the eyes due to minor eye irritations
• for use as a protectant against further irritation or to relieve dryness of the eye

WARNINGS

Warnings

For external use only

ASK DOCTOR

Ask a doctor before use if you have narrow angle glaucoma.

PURPOSE

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 right away.

INDICATIONS & USAGE

Directions

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

OTHER SAFETY INFORMATION

Other information

• store at 15° to 25°C (59° to 77°F)

INACTIVE INGREDIENT

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

DOSAGE & ADMINISTRATION

Distributed by:

United Exchange Corp.

Cypress, CA 90630 USA

Made in South Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FAMILY CARE ADVANCED FORMULA EYE 
tetrahydrozoline hydrochloride, dextran 70, polyethylene glycol 400, povidone solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-511
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.5 mg  in 1 mL
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-511-15	1 in 1 CARTON	11/25/2014
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	11/25/2014

Labeler - United Exchange Corp (840130579)