Label: SORE THROAT- phenol spray

  • NDC Code(s): 68163-703-06
  • Packager: Raritan Pharmaceuticals 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 September 2, 2023

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  • Active Ingredient(s)

    Phenol 1.4%

  • Purpose

    Oral pain reliever

  • Use(s)

    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 that 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 6 years of age unless directed by doctor.

  • When using this product

    do not exceed recommended dosage.

  • Stop use and ask a 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

    If more than used for minor mouth or throat pain is accidentally swallowed, 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 the affected area (one spray). Allow to remain in place for at least 15 seconds, and then spit out.
    ▪
    Use every 2 hours or as directed by a doctor or dentist.
    ▪
    Children 6 years to under 12 years of age: should be supervised in the use of this product.
    ▪
    Children under 6 years: Consult 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?

    1-866-467-2748

  • Principal Display Panel

    *Compare to the active ingredient in Chloraseptic®

    NDC# 68163-703-06

    SORE THROAT SPRAY

    Phenol/Oral Pain Reliever

    Fast Acting

    Numbs on Contact

    SUGAR-FREE

    ASPIRIN-FREE

    NATURAL CHERRY FLAVOR

    6 FL OZ (177 mL)

    Tamper-Evident: Do not use if imprinted shrink band is broken or missing.

    Distributed by:

    *This product is not manufactured or distributed by Prestige Brands Inc., owner of the registered trademark Chloraseptic®.

    DRx Sore Throat Spray
  • INGREDIENTS AND APPEARANCE
    SORE THROAT 
    phenol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-703
    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
    FlavorCHERRY (Natural Cherry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68163-703-06177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/29/2020
    Labeler - Raritan Pharmaceuticals Inc (127602287)
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