Label: FAMILY CARE NASAL RELIEF - oxymetazoline hydrochloride spray 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 06/13

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient                                                                                 Purpose

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

    Close
  • PURPOSE

    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
    Close
  • WARNINGS

    Warnings For nasal use only

    Close
  • ASK DOCTOR

    Ask a doctor before use if you have

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

    Stop use and ask a doctor if symptoms persist

    Close
  • PREGNANCY OR BREAST FEEDING

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

    Close
  • 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.

    Close
  • 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.
    • 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.
    Close
  • STORAGE AND HANDLING

    Other information

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

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

    Close
  • DOSAGE & ADMINISTRATION

    Distributed By:

    United Exchange Corp

    17211 Valley View Ave.

    Cerritos, CA 90703 USA

    Made in Korea

    Close
  • INGREDIENTS AND APPEARANCE
    FAMILY CARE NASAL RELIEF 
    oxymetazoline hydrochloride spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:65923-551
    Route of Administration NASAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE) OXYMETAZOLINE HYDROCHLORIDE 0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE  
    BENZYL ALCOHOL  
    EDETATE DISODIUM  
    SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE  
    POLYETHYLENE GLYCOL 1450  
    POVIDONE K30  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65923-551-30 1 in 1 CARTON
    1 30 mL in 1 BOTTLE
    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)
    Close