Label: MAXIMUM STRENTH NASAL- oxymetazoline hydrochloride - 0.05% liquid

  • Category: HUMAN OTC DRUG LABEL

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 February 19, 2018

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  • Active ingredient                                            Purpose

    Oxymetazoline Hydrochloride - 0.05%           Nazal Decongestant

  • PURPOSE

  • Uses

    For the temporary relief of nasal congestion due to the common cold, hay fever or other upper respiratory allergies.

  • Warnings

    Do not use this product if person has heart disease, high blood pressure, thyroid disease, diabetes, or if adult has difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

    When using this product

    Do not exceed recommended dosage

    Do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor.This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge. The use of this container by more than one person may spread infection.

  • Keep out of reach of children. If product is 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 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.

  • Inactive ingredients

    Benzalkonium Chloride
    Camphor
    Disodium EDTA
    Eucalyptol
    Glycine
    Menthol
    Polysorbate 80
    Propylene Glycol
    Sodium Chloride
    Sodium Hydroxide
    Water

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENTH NASAL 
    oxymetazoline hydrochloride - 0.05% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-7003
    Route of AdministrationTOPICAL
    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
    Benzalkonium Chloride (UNII: F5UM2KM3W7)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Eucalyptol (UNII: RV6J6604TK)  
    Glycine (UNII: TE7660XO1C)  
    Menthol (UNII: L7T10EIP3A)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-7003-011 in 1 CARTON07/15/2016
    122 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/15/2016
    Labeler - Walgreens (008965063)
    Registrant - Product Quest Mfg. (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg.927768135manufacture(0363-7003) , label(0363-7003)
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