Label: TOPCARE CHERRY FLAVOR- phenol spray

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

Drug Label Information

Updated November 20, 2023

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  • Active ingredient

    Phenol 1.4%

  • Purpose

    Oral Anesthetic/Analgesic

  • Uses

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

  • Warnings

    Sore throat warning: Severe or persistent sore throat or sore throat 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 dosage.

    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 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 12 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, 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?

    1-888-423-0139

  • Principal Display Panel

    TopCare® health™

    COMPARE TO CHLORASEPTIC® ACTIVE INGREDIENT*

    NDC# 36800-600-06

    SUGAR-FREE

    Sore Throat Spray

    PHENOL/ORAL ANESTHETIC

    •
    Works on Contact
    •
    Relieves Sore Throat Pain
    •
    Fast Acting

    ASPIRIN-FREE

    ALCOHOL-FREE

    CHERRY FLAVOR

    6 FL OZ (177 mL)

    OUR PHARMACIST RECOMMEND

    QUALITY GUARANTEED

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

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SHRINK BAND IS BROKEN OR MISSING

    DISTRIBUTED BY

    TOPCO ASSOCIATES LLC,

    ELK GROVE VILLAGE, IL 6007

    TOPCO RARA1217

    QUESTIONS? 1-888-423-0139

    topcare@topco.com www.topcarebrand.com

  • Package Label

    Topcare Sore Throat Cherry Flavor

    TopCare Sore Throat Spray Cherry Flavor

  • INGREDIENTS AND APPEARANCE
    TOPCARE  CHERRY FLAVOR
    phenol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-600
    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:36800-600-06177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/05/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02203/05/2019
    Labeler - TOPCO ASSOCIATES, LLC (006935977)
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