FAMILY WELLNESS IRRITATION RELIEF AC EYE DROPS- tetrahydrozoline hydrochloride and zinc sulfate solution

FAMILY WELLNESS IRRITATION RELIEF AC EYE DROPS by

Drug Labeling and Warnings

FAMILY WELLNESS IRRITATION RELIEF AC EYE DROPS 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

Tetrahydrozoline HCL 0.05% ...........................................................Redness Reliever

Zinc Sulfate 0.25% .........................................................................Astringent

PURPOSE

Uses

• for temporary relief of discomfort and redness of the eye due to minor eye irritations

WARNINGS

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 become 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 lasts
• 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 counterclockwise. To close bottle, twist clockwise until it stops turning.
• Put 1 to 2 drops in the affected eye(s) up to 4 times daily
• Children under 6 years of age: Ask a doctor

STORAGE AND HANDLING

Other information

• some users may experience a brief tingling sensation
• store at 15° to 25°C (59° to 77°F)

INACTIVE INGREDIENT

Inactive ingredients

Benzalkonium Chloride, Boric Acid, Edetate Disodium, Purified Water, Sodium Chloride, Sodium Citrate

DOSAGE & ADMINISTRATION

DISTRIBUTED BY:

FAMILY DOLLAR SERVICES, INC.

10401 MONROE RD

MATTHEWS, NC 28105 USA

MADE IN KOREA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS IRRITATION RELIEF AC EYE DROPS 
tetrahydrozoline hydrochloride and zinc sulfate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-323
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
ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37)	ZINC SULFATE	2.5 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 CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-323-15	1 in 1 CARTON	03/23/2017
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	10/31/2012

Labeler - FAMILY DOLLAR (024472631)