Label: SORE THROAT RELIEF CHERRY FLAVOR- 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

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

  • Active ingredient

    Phenol 1.4%

  • Purpose

    Oral Anesthetic/Analgesic

  • Uses

    For the temporary relief of occasional minor irritation, pain, sore mouth and sore throat.

  • Warnings

    Sore throat warning: Severe or persistent sore throat or sore throat that accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 6 years of age unless directed by a doctor.

    When using this product,

    do not exceed recommended dose.

    Stop use and ask a doctor or dentist 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

    Apply to affected area (one spray). Allow to remain in place for at least 15 seconds, then spit out.

    Adults and children 12 year of age and older

    Use every 2 hours or as directed by a doctor or dentist

    Children under 12 years of age

    Should be supervised in use of this product

    Children under 6 years of age

    Ask a doctor or dentist

  • Other information

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

    FD&C Red No. 40, flavor, glycerin, purified water, sucralose.

  • Questions or comments?

    1-866-467-2748

  • Principal Display Panel

    NDC# 70000-0458-1

    Sore Throat Spray

    Phenol 1.4%

    Oral Anesthetic / Analgesic

    Cherry Flavor

    Sore Throat Relief

    Sugar-Free

    6 FL. OZ. (177 mL)

    100% Money Back Guarantee

    Return to place of purchase.

    Aspirin-Free

    COMPARE TO CHLORASEPTIC® active ingredient*

    TAMPER EVIDENT: Do not use if imprinted shrink band is broken or missing.

    *This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Chloraseptic®.

    ©2018 CARDINAL HEALTH, the Cardinal Health LOGO, LEADER and the Leader LOGO are trademark or registered trademarks of Cardinal Health.

    www.myleader.com 1-800-200-6313

    Leader Cherry Flavor Sore Throat Phenol 1.4%
  • INGREDIENTS AND APPEARANCE
    SORE THROAT RELIEF  CHERRY FLAVOR
    phenol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0458
    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
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0458-1177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/12/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35602/12/2019
    Labeler - Cardinal Health (063997360)