Label: CHLORASEPTIC WARMING SORE THROAT- phenol spray

  • NDC Code(s): 67172-212-31
  • 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 April 25, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Phenol 1.4%

  • Purpose

    Oral pain reliever

  • 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 a doctor promptly. Do not use more than 2 days or give 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 professional before use.

    Keep out of reach of children.

    If more than used for minor mouth or throat pain is accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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
    • contains FD&C yellow 5 (tartrazine) as a color additive
  • Inactive ingredients

    caramel color, citric acid, FD&C yellow no. 5, FD&C yellow no.6, glycerin, flavors, purified water, saccharin sodium, sodium citrate, sucralose

  • Questions?

    1-800-552-7932

  • PRINCIPAL DISPLAY PANEL

    Chloraseptic
    w    arming
    SORE THROAT

    H    ONEY LEMON 6 FL OZ (177 mL) SPRAY

    PRINCIPAL DISPLAY PANEL Chloraseptic warming SORE THROAT HONEY LEMON 6 FL OZ (177 mL) SPRAY

  • INGREDIENTS AND APPEARANCE
    CHLORASEPTIC WARMING SORE THROAT 
    phenol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67172-212
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67172-212-31177 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/01/2012
    Labeler - Prestige Brands Holdings, Inc. (159655021)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmaceuticals, LLC001207208manufacture(67172-212)
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