Label: SOUND BODY 12 HOUR NASAL ORIGINAL- oxymetazoline hydrochloride spray

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

DISCLAIMER: 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 Information

Updated June 19, 2013

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  • Active ingredient

    Oxymetazoline Hydrochloride, 0.05%

  • Purpose

    Nasal Decongestant

  • Uses

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

  • Ask a doctor before use if you have

    • Heart disease
    • High blood pressure
    • Diabetes
    • Thyroid disease
    • 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

    Stop use and ask a doctor if symptoms persists.

  • 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.

  • Directions

    • Adults and children 6 to under 12 years of age (with adult supervision):  2 or 3 sprays in each nostril not more ofter 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.
    • To spray, squeeze bottle quickly and firmly.  Do not tilt head backwards while spraying. Wipe nozzle clean after use.
  • Other information

    • Store between 20° - 25° C (68° - 77° F)
    • Retain carton for future reference on full labeling.
  • Inactive ingredients

    Benzalkonium chloride, edetate disodium, glycerin, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

  • PRINCIPAL DISPLAY PANEL

    image of label

  • PRINCIPAL DISPLAY PANEL

    image of carton

  • INGREDIENTS AND APPEARANCE
    SOUND BODY 12 HOUR NASAL  ORIGINAL
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:23558-5120
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE50.0 mg  in 100.0 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23558-5120-01 in 1 CARTON
    1NDC:23558-5120-130 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/31/2008
    Labeler - Lee Pharmaceuticals (056425432)
    Registrant - Lee Pharmaceuticals (056425432)
    Establishment
    NameAddressID/FEIBusiness Operations
    Samson Pharmaceuticals088169581manufacture(23558-5120)