Label: SORE THROAT- phenol spray 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/13

If you are a consumer or patient please visit this version.

  • Active ingredient

    Phenol 1.4%

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  • Purpose

    Oral anesthetic/analgesic

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  • Uses

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

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  • Warnings

    Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, or vomiting may be serious. Consult doctor promptly. 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 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 pain is accidentally swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

    Directions

    Adults and children 3 years of age and older:

    apply to the affected are (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

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  • Other information

    store at 20-25°C (68-77°F)

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  • Inactive ingredients

    FD&C red #40, flavor, glycerin, purified water, saccharin sodium

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    Compare to Chloraseptic® active ingredient

    See New Directions

    Instant Acting / Relieves Sore Throat

    Sore Throat Spray

    Phenol/Oral Anesthetic

    Fast Relief

    Cherry Flavor

    Alcohol Free

    Aspirin Free

    Sugar Free

    6 FL OZ (177 mL)

    Hy Vee Sore Throat Spray.jpg
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  • INGREDIENTS AND APPEARANCE
    SORE THROAT 
    phenol spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:42507-328
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PHENOL (PHENOL) PHENOL 1.4 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    FD&C RED NO. 40  
    GLYCERIN  
    WATER  
    SACCHARIN SODIUM  
    Product Characteristics
    Color RED (clear) Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42507-328-30 177 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 11/19/1992
    Labeler - HyVee Inc (006925671)
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