Your browser does not support JavaScript! FAMILY CARE NASAL RELIEF (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [UNITED EXCHANGE CORP]
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FAMILY CARE NASAL RELIEF (oxymetazoline hydrochloride) spray
[United Exchange Corp]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

Active ingredient                                                                                 Purpose

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

Uses

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

Warnings For nasal use only

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 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 and ask a doctor if symptoms persist

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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.
  • shake well before use. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use.
  • children under 6 years of age: ask a doctor.

Other information

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

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

Distributed By:

United Exchange Corp

17211 Valley View Ave.

Cerritos, CA 90703 USA

Made in Korea

image of carton label

FAMILY CARE NASAL RELIEF 
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:65923-551
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE) OXYMETAZOLINE HYDROCHLORIDE0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
BENZYL ALCOHOL 
EDETATE DISODIUM 
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE 
POLYETHYLENE GLYCOL 1450 
POVIDONE K30 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65923-551-301 in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/30/2013
Labeler - United Exchange Corp (840130579)

Revised: 6/2013
 
United Exchange Corp

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