Label: PHENOL spray

  • NDC Code(s): 83324-031-06
  • Packager: CHAIN DRUG MARKETING ASSOCIATION INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2024

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

  • Active Ingredient                         Purpose

    Phenol 1.4%............. Oral Anesthetic/Analgesic

  • PURPOSE

    Sore Throat Relief

  • Uses

    • For temporary relief of occasional minor throat irritation, pain, sore mouth, sore throat.
  • Warnings

    Sore throat waring: Severe and persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor.

    Whan using this product do not exceed recommended dose. Do not use more than 2 days. Use only as directed. Use of this container by more
    than one person may spread infection.

  • STOP USE

    Stop use and ask a doctor or dentist if

    • sore throat symptoms do not improve in 7 days 
    • irritation, pain or redness persists or worsens
    • swelling, rash or fever develops

    If pregnant or breast-feeding ask a doctor before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 3 years of age and older.

    • Apply to the affected area (one spray) 
    • Allow to remain in place for at least 15 seconds, then spit out 
    • Use every 2 hours or as directed by a doctor or dentist. Children under 12 years of age should be supervised in the use of this product. Children under 3 years of age, consult a doctor or dentist
    • Before using the first time, remove the protective neck band and dust cap from the tip. To spray hold bottle straight up and press the
      nozzle with index finger without tilting head. Fully depress pump all the way down with a firm, even stroke. Wipe nozzle dry.
  • Other information

    • Store at room temperature
  • Inactive ingredients

    cherry flavor, FD&C Red #40, glycerin, purified water, sodium saccharin.

  • SPL UNCLASSIFIED SECTION

    • Tamper Evident: Do not use if printed shrink band is broken or missing.
    • This product is not manufactured or distributed by Prestige Brands Inc., distributor of Chloraseptic.

    Questions or comments?
    call 866-200-8310 (Mon-Fri. 9 am-5 pm EST)

    Distributed by C.D.M.A Inc.
    Novi, MI 48375
    www.qualitychoice.com
    Question: 800-935-2362

  • PRINCIPAL DISPLAY PANEL

    NDC-83324-031-06

    containerlabel

  • INGREDIENTS AND APPEARANCE
    PHENOL 
    phenol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83324-031
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL14 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM SACCHARIN (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83324-031-06177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/12/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02212/12/2024
    Labeler - CHAIN DRUG MARKETING ASSOCIATION INC. (011920774)
    Registrant - Seaway Pharma Inc. (117218785)
    Establishment
    NameAddressID/FEIBusiness Operations
    Seaway Pharma Inc.117218785manufacture(83324-031)