Label: NICE SORE THROAT CHERRY- 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 December 21, 2020

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  • Drug Facts

  • Active Ingredients & Purposes

    Active IngredientsPurposes
    Phenol 1.4%Oral Anesthetic/ Analgesic

  • Uses

    For temporary relief of occasional minor irritation, pain, sore mouth, sore throat and pain associated with canker sores.

  • Warnings

    Sore throat warning: Severe or 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 doctor.

    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
    • difficulty in breathing occurs

    If pregnant or breast feeding,

    • ask a health professional before use.

    Keep this and all drugs out of reach of children.

    In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away.

  • Directions

    • apply to the affected area
    • 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
    agedose
    adults and children 12 years of age and olderfor each application, spray 5 times
    children 3 to under 12 years

    should be supervised in use of this product;

    for each application, spray 3 times
    children under 3 years of ageconsult a doctor or dentist
  • Other Information

    • store at room temperature

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL IS TORN, BROKEN OR MISSING.

  • Inactive Ingredients

    citric acid, FD&C red #40, flavor, glycerin, propylene glycol, sodium citrate, sodium saccharin, and water.

  • Questions?

    1-855-452-9500 or email at info@leosonsintl.com

  • Distributed by:

    LEOSONS
    Albany, New York 12205

    MADE IN THE USA

  • Principal Display Panel

    • Sugar Free
    • Alcohol Free
    • Aspirin Free

    N'ICE®

    PHENOL/ ORAL ANESTHETIC

    Sore Throat Spray

    Fast acting, long lasting relief of minor sore throat and mouth pain

    Cherry Flavor

    6 FL OZ (177 mL)

    NICE Throat Cherry

  • INGREDIENTS AND APPEARANCE
    NICE SORE THROAT CHERRY 
    phenol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69626-0047
    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
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69626-0047-6177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/07/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35603/07/2014
    Labeler - Leosons Overseas Corp (148605470)
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