Label: SORE THROAT RELIEF- phenol spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 October 4, 2023

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  • Active ingredient

    Phenol 1.4%

  • Purpose

    Oral Anesthetic/Analgesic

  • Uses

    temporarily relieves sore throat pain, sore mouth, pain associated with canker sores, minor mouth irritation

  • Warnings

    Sore throat warning: Severe or persistent sore throat or sore throat that occurs with high fever, headache, nausea, and vomiting may be serious. Ask a doctor right away. Do not use more than 2 days or give to children under 3 years of age.

    When using this product,

    do not use more than directed.

    Stop use and ask a doctor if

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

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • apply to the affected area
    • use every 2 hours
    • allow to remain in place for at least 15 seconds, then spit out
    agedose 
     adults and children 12 years and over for each application, spray 5 times 
     children 3 to 11 years should be supervised in use of this product for each application, spray 3 times
     children under 3 years ask a doctor or dentist
  • Other information

    • store at 20º-25ºC (68º-77ºF). Do not refrigerate.
  • Inactive ingredients

    alcohol, FD&C red #40, glycerin, natural & artificial flavor, purified water, saccharin sodium

  • Questions?

    Or to report an adverse event call 800-824-1706 Monday-Friday 9am-4pm MST

  • Principal Display Panel

    *Compare to the active ingredient in Chloraseptic®*

    Instant Acting 

    Sore Throat Relief

    Phenol/Oral Anesthetic

    Alcohol 0.10%

    Relieves Sore Throat Pain

    Cherry Flavor

    Artificially Flavored

    FL OZ (mL)

    *This product is not manufactured or distributed by Prestige Brands, Inc., distributor of Chloraseptic®.

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED WRAP AROUND THE CAP IS BROKEN OR TORN.

    DISTRIBUTED BY:

    WINCO FOODS LLC

    BOISE, ID 83704

    *This product is not manufactured or distributed by Prestige Brands Inc., distributor of Chloraseptic®

  • Package Label

    Phenol 1.4%

    WinCo Foods Sore Throat Relief Spray

  • INGREDIENTS AND APPEARANCE
    SORE THROAT RELIEF 
    phenol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-267
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL1.4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67091-267-17177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/31/201412/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35612/31/201412/31/2024
    Labeler - WinCo Foods, LLC (056098817)
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