Label: PHENOL- sore throat spray spray

  • 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 June 15, 2015

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  • ACTIVE INGREDIENT

    Active Ingredient:
    Phenol 1.4%

  • PURPOSE

    Purpose: Oral Anesthetic/ Analgesic

  • INDICATIONS & USAGE

    Uses

    • For the temporary relief of occasional minor throat:
      1. Irritation
      2. Pain
      3. Sore Mouth
      4. Sore Throat
  • WARNINGS

    Warnings

    Sore Throat Warnings:
    Severe and persisttent 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.

    • do not exceed recommended dose
    • do not use for more than 2 days. Use only aas directed.
    • use of this container by more than one person may spread infection.

    Stop use and ask doctor or dentist if sore throat symptoms do not improve in 7 days Irritation, pain or redness persists or worsens. Swelling, rash or fever develops.

  • WHEN USING

    • do not exceed recommended dose
    • do not use for more than 2 days. Use only aas directed.
    • use of this container by more than one person may spread infection.
  • PREGNANCY OR BREAST FEEDING

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose or accidental poisioning, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    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
    • Before using the first time, remove the protective neck band and dust cap from the tip. To spray, hold bottle straight up and press on the nozzle with index finger without tiltting head. Fully depress pump all the way down with a firm even stroke. Wipe nizzle dry.
  • STORAGE AND HANDLING

    Other information

    • Store at room temperature
    • Temper Evident: Do not use if printed neck band is broken or missing
    • Check expiration date before using
  • INACTIVE INGREDIENT

    Inactive ingredients are: Sodium Saccharin, Glycerin, Purified water, FD&C red# 40, Cherry Flavour.

  • HOW SUPPLIED

    Manufactured in USA by
    Purinepharma LLC

    5 County Route 42
    Massena, NY 13662
    A MEDIBEST Brands Company

    Questions: www.purinepharma.com
    Tel: 1-315-705-4030
    NDC: 58599-008-06

  • PRINCIPAL DISPLAY PANEL

    Medpurine Container Label
  • INGREDIENTS AND APPEARANCE
    PHENOL 
    sore throat spray spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58599-008
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL1.4 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    CHERRY (UNII: BUC5I9595W)  
    Product Characteristics
    ColorRED (Red) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58599-008-0130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    2NDC:58599-008-06177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35603/01/2015
    Labeler - PURINEPHARMA LLC (019950491)
    Registrant - PURINEPHARMA LLC (019950491)
    Establishment
    NameAddressID/FEIBusiness Operations
    PURINEPHARMA LLC019950491MANUFACTURE(58599-008)
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