Label: CHLORASEPTIC SORE THROAT MAX- phenol and glycerin spray

  • NDC Code(s): 67172-937-04, 67172-937-52
  • Packager: Prestige Brands Holdings, Inc.
  • 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 11, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Phenol 1.5%

  • Purpose

    Oral Anesthetic/Analgesic

  • Active Ingredients

    Glycerin 33%

  • Purpose

    Demulcent

  • Uses

    for the temporary relief of ■ occasional minor irritation, pain, sore mouth and sore throat ■ minor discomfort and protection of irritated areas in 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 3 years of age unless directed by a doctor.

    When using this product

    do not exceed recommended dosage.

    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.

  • 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 by an adult 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, purified water, sodium saccharin, sucralose

  • Questions?

    1-800-552-7932 Chloraseptic.com

  • PRINCIPAL DISPLAY PANEL


    Chloraseptic® Max Sore Throat

    Phenol Oral Anesthetic /Demulcent Spray  1 fl oz (30 mL) | Wild Berries

    Chloraseptic® Max Sore Throat Phenol Oral Anesthetic /Demulcent Spray 1 fl oz (30 mL) | Wild Berries

  • INGREDIENTS AND APPEARANCE
    CHLORASEPTIC SORE THROAT MAX 
    phenol and glycerin spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67172-937
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL15 mg  in 1 mL
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN330 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67172-937-521 in 1 BOX02/01/2011
    130 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    2NDC:67172-937-041 in 1 BOX06/01/2021
    2118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35602/01/2011
    Labeler - Prestige Brands Holdings, Inc. (159655021)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmaceuticals, LLC001207208MANUFACTURE(67172-937)
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