FAMILY CARE NASAL RELIEF- oxymetazoline hydrochloride spray

Family Care Nasal Relief by

Drug Labeling and Warnings

Family Care Nasal Relief 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 ingredient                                                               Purpose

Oxymetazoline HCl 0.05%.................................................Nasal Decongestant

PURPOSE

Uses

• Temporarily relieves nasal congestion due to:
• common cold
• hay fever
• upper respiratory allergies
• shrinks swollen nasal membranes so you can breathe more freely
• temporarily relieves sinus congestion and pressure

WARNINGS

Warnings

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland

WHEN USING

When using this product

• do not use more than directed
• do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen
• temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur
• use of this container by more than one person may spread infection

STOP USE

Stop use and ask a doctor if symptoms persist

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 right away.

INDICATIONS & USAGE

Directions

• adults and children 6 to 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
• children under 6 years of age: ask a doctor. Shake well before use. To open, rotate cap to align the marks. Squeeze cap on both sides in a counter-clockwise turn and pull off to remove. To spray, remove clamp and hold bottle with thumb at base and nozzle between first and second fingers. Without tilting the head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use and snap cap back onto bottle.

STORAGE AND HANDLING

Other information

• store between 20° and 25°C (68° and 77°F)
• retain carton for future reference on full labeling

INACTIVE INGREDIENT

Inactive ingredients benzalkonium chloride, benzyl alcohol, dibasic sodium phosphate hydrate, disodium EDTA, distilled water, monobasic sodium phosphate dihydrate, PEG 1450, PVP K30

DOSAGE & ADMINISTRATION

Distributed By:

United Exchange Corp

17211 Valley View Ave.

Cerritos, CA 90703 USA

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FAMILY CARE NASAL RELIEF 
oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-551
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)
POVIDONE K30 (UNII: U725QWY32X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-551-30	1 in 1 CARTON	11/02/2016
1		15 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/30/2013

Labeler - United Exchange Corp (840130579)