FAMILY CARE NASAL RELIEF (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [UNITED EXCHANGE CORP]

FAMILY CARE NASAL RELIEF (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [UNITED EXCHANGE CORP]
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NDC 65923-570-15
Set ID 6d0eef2f-f546-d769-e053-2991aa0a8fe4
Category HUMAN OTC DRUG LABEL
Packager United Exchange Corp
Generic Name
Product Class
Product Number
Application Number PART341
  • 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 (1-800-222-1222) right away.

  • INDICATIONS & USAGE

    Directions

    • adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
    • children under 6 years of age: consult a doctor. Shake well before use. Remove safety seal. 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, edetate disodium, polyethylene glycol 1500, povidone k30, purified water, sodium phosphate dibasic, sodium phosphate monobasic Monohydrate

  • DOSAGE & ADMINISTRATION

    Distributed By:

    United Exchange Corp

    Cypress, CA 90630 USA

    1-888-645-8204

    Made in China

  • PRINCIPAL DISPLAY PANEL

    570

  • INGREDIENTS AND APPEARANCE
    FAMILY CARE NASAL RELIEF 
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-570
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BENZODODECINIUM CHLORIDE (UNII: Y5A751G47H)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-570-151 in 1 CARTON05/21/2018
    115 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/30/2013
    Labeler - United Exchange Corp (840130579)

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