Label: SORE THROAT RELIEF CHERRY- phenol spray

  • NDC Code(s): 70000-0277-1
  • Packager: Cardinal Health (Leader) 70000
  • 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 January 12, 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 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 3 years of age unless directed by a doctor.

    When using this product,

    do not exceed recommended dose.

    Stop use and ask a dentist or 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 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

    • adults and children 6 years of age and older
      • apply to affected area (one spray)
      • allow to remain in place for at least 15 seconds,then spit out
      • use every 2 hours as directed by a doctor or dentist
    • 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 between 20-25ºC (68-77ºF). Do not refrigerate.
  • Inactive ingredients

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

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    Sore Throat Spray

    Phenol 1.4%

    Oral Anesthetic / Analgesic

    Cherry Flavor

    Relieves Sore Throat

    Alcohol 0.10%

    Aspirin Free

    Sugar Free

    FL OZ (mL)

    COMPARE TO CHLORASEPTIC® active ingredient*

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

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND CAP IS BROKEN OR TORN.

    DISTRIBUTED BY CARDINAL HEALTH

    DUBLIN, OHIO 43017

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

  • Package Label

    Phenol 1.4%

    LEADER Sore Throat Spray Cherry Flavor

  • INGREDIENTS AND APPEARANCE
    SORE THROAT RELIEF  CHERRY
    phenol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0277
    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
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0277-1177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/31/201712/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35603/31/201712/31/2024
    Labeler - Cardinal Health (Leader) 70000 (063997360)
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