RUGBY CHERRY FLAVOR (PHENOL) SPRAY [RUGBY LABORATORIES]

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RUGBY CHERRY FLAVOR (PHENOL) SPRAY [RUGBY LABORATORIES]
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NDC 0536-1228-58
Set ID 3d668c78-8130-45d4-bcb7-dddcb2fbe7a3
Category HUMAN OTC DRUG LABEL
Packager RUGBY LABORATORIES
Generic Name
Product Class
Product Number
Application Number PART356
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  • Active ingredient

    Phenol 1.4%

  • Purpose

    Oral Anesthetic/Analgesic

  • Uses

    For the temporarily 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 administer to children under 6 years of age unless directed by a doctor.

    When using this product,

    do not exceed recommended dosage.

    Stop use and ask a dentist or 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.

    In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    •
    Adults and children 12 years of age and older
    •
    apply to affected area (one spray)
    •
    allow to remain in place for at least 15 seconds, then spit out
    •
    use every 2 hours as directed by a doctor or dentist
    •
    Children under 12 years of age: should be supervised in the use of this product
    •
    Children under 6 years of age, Ask 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?

    1-800-645-2158

  • Principal Display Panel

    *COMPARE TO THE ACTIVE INGREDIENT IN CHLORASEPTIC®

    NDC# 0536-1228-58

    Rugby®

    SUGAR-FREE

    CHERRY Phenaseptic

    Oral Anesthetic/Analgesic

    For Relief of Minor

    Sore Throat Pain

    Phenol 1.4%

    Naturally and Artificially Flavored

    Aspirin Free

    Sugar Free

    6 FL OZ (177 mL)

    *This product is not manufactured or distributed by Prestige Brands, Inc., distributor of Chloraseptic®.

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SHRINK BAND IS BROKEN OR MISSING

    Distributed by:

    Rugby Laboratories

    17177 N Laurel Park Drive, Suite 233

    Livonia, MI 48152

    www.rugbylaboratories.com

  • Package Label

    Rugby Sugar Free Cherry Flavor Phenaseptic Phenol 1.4%

    Rugby Sore Throat Spray Cherry Flavor

  • INGREDIENTS AND APPEARANCE
    RUGBY  CHERRY FLAVOR
    phenol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1228
    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
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1228-58177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/05/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35604/05/2019
    Labeler - RUGBY LABORATORIES (079246066)
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