Label: CHLORASEPTIC SORE THROAT (KIDS GRAPE) GRAPE- phenol spray

  • NDC Code(s): 0295-9355-23
  • Packager: Denison Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL

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 March 7, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Phenol 0.5%

  • 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 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 a doctor.


    When using this product

    do not exceed recommended dosage.

    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 health care professional 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.

  • Directions

    Adults and children 3 years of age and older:

    • Apply to the affected area (one spray).
    • 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. Children under 12 years of age should be supervised in the use of this product. Children under 3 years of age: consult a doctor or dentist.
  • Other information

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

    FD&C blue no. 1, FD&C red no.40, flavor, glycerin, purified water, sodium saccharin, sodium chloride

  • Questions?

    1-800-552-7932 www.chloraseptic.com

  • PRINCIPAL DISPLAY PANEL

    Kids Chloraseptic ®

    Phenol/Oral Anesthetic

    SORE THROAT

    Real Relief, Real Fast ®

    GRAPE | 6 fl oz (177 mL)

    label

  • INGREDIENTS AND APPEARANCE
    CHLORASEPTIC SORE THROAT (KIDS GRAPE)  GRAPE
    phenol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-9355
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL3.5 mg  in 0.7 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Product Characteristics
    ColorpurpleScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0295-9355-23177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/07/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35603/07/2019
    Labeler - Denison Pharmaceuticals, LLC (001207208)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmaceuticals, Inc.001207208manufacture(0295-9355)