Label: SORE THROAT RELIEF MENTHOL- phenol spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 2023

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

  • 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

    sore mouth 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.

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

  • Directions

     
    Adults and children 6 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
     
    Children under 12 years of age should be supervised in the use of this product
     
    Children under 6 years of age: consult a doctor or dentist
  • Other information

    Store at room temperature
    Check expiration date before using
  • Inactive ingredients

    D&C Green #5, D&C Yellow #10, FD&C Green #3, flavor, glycerin, purified water, sucralose

  • Principal Display Panel

    *Compare to the active ingredient in Chloraseptic®*

    Sore Throat Relief

    Menthol Flavor

    Fast acting relief of Minor Sore Throat and Mouth Pain

    Phenol/Oral Anesthetic

    Sugar-Free

    Aspirin-Free

    Gluten-Free

    Alcohol-Free

    6 FL OZ (177 mL)

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

    Tamper-Evident: Do not use if imprinted shrink band is broken or missing.

    DISTRIBUTED BY:

    Chain Drug Consortium LLC.

    3301 N.W. Boca Raton Blvd.

    Suite 101, Boca Raton FL 33431

  • Package Label

    Premier Value Sore Throat Spray Menthol Flavor
  • INGREDIENTS AND APPEARANCE
    SORE THROAT RELIEF  MENTHOL
    phenol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-343
    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
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorMENTHOLImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-343-06177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/31/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02212/31/2014
    Labeler - Chain Drug Consortium (101668460)