FAMILY CARE ULTRA LUBRICANT- polyethylene glycol 400, and propylene glycol solution/ drops

Family Care Ultra Lubricant by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active ingredients Purpose

Polyethylene Glycol 400 0.4%....................... Eye lubricant

Propylene Glycol 0.3%....................................Eye lubricant

PURPOSE

Uses

• for the temporary relief of burning and irritation due to:
• dryness of the eyes
• exposure to wind or sun

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use

• if this product changes color or becomes cloudy
• if you are sensitive to any ingredient is this product

WHEN USING

When using this product

• remove contact lenses before use
• replace cap after each use
• do not touch tip of bottle to any surface to avoid contamination

STOP USE

Stop use and ask a doctor if

• you experience eye pain and/or vision change
• you continue to have eye redness and/or irritation
• irritation, burning persists or worsens for 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 reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

INDICATIONS & USAGE

Directions

• shake well before using
• instill 1 or 2 drops in the affected eye(s) as needed
• children under 6 years of age: ask a doctor

STORAGE AND HANDLING

INACTIVE INGREDIENT

Inactive ingredients

benzalkonium chloride, boric acid, hypromellose, hydrochloric acid, potassium chloride, purified water, sodium chloride, sodium hydroxide

DOSAGE & ADMINISTRATION

Distributed by:

United Exchange Corp,

Cypress, CA 90630 USA

1-888-645-8204

Made in South Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FAMILY CARE ULTRA LUBRICANT 
polyethylene glycol 400, and propylene glycol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-588
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	4 mg  in 1 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
HYDROCHLORIC ACID (UNII: QTT17582CB)
WATER (UNII: 059QF0KO0R)
BORIC ACID (UNII: R57ZHV85D4)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-588-15	1 in 1 CARTON	07/22/2024
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M018	07/22/2024

Labeler - United Exchange Corp. (840130579)