Label: SORE THROAT CHERRY- phenol spray

  • NDC Code(s): 63868-811-55
  • Packager: QUALITY CHOICE (Chain Drug Marketing Association)
  • 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 May 11, 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 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 comments?

    Call 1-248-449-9300 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    *Compare to the Active Ingredient in Chloraseptic®

    Sore Throat Spray

    Oral anesthetic/analgesic

    Phenol

    Fast acting/long lasting

    Alcohol 0.10%

    Cherry flavor

    FL OZ (mL)

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

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

    Distributed by C.D.M.A., Inc.©

    43157 W. Nine Mile

    Novi, MI 48376-0995

    www.qualitychoice.com

  • Package Label

    Phenol 1.4%

    Quality Choice Sore Throat Spray

  • INGREDIENTS AND APPEARANCE
    SORE THROAT  CHERRY
    phenol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-811
    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:63868-811-55177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/31/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35608/31/2014
    Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)
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