Label: LEMON GLYCERIN- glycerin swab

  • 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 December 18, 2013

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  • Active Ingredient

    Active Ingredient                                     Purpose

    Glycerin 7.5% v/v                                  Oral Demulcent

  • Purpose

    Purpose

    For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

  • Warnings

    Warning:

    For Oral Use Only.

    • Do not get in eyes.
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Indications and Usage

    Indications and Usage

    • For temporary relief of minor soreness and/or irritation of the mouth.
    • Dry mouth relief.
  • Dosage and Administration

    Dosage and Administration

    Administration

    • Swab mouth as needed.
    • Discard after single use.

    Dosage

    • Children under the age of 12 should be supervised in the use of this product.
    • Children under 2 years of age consult a doctor.
  • Other information

    Other information:

    • Store at room temperature. 15 deg - 30 deg C, 58 deg - 86 deg F
    • Avoid excessive heat.
  • Inactive ingredients:

    Inactive ingredients: Citric acid, lemon flavor, sodium benzoate, water

  • Principal Display Panel

    Cardinal Lemon Swab.jpg

    Cardinal Lemon Swab

  • INGREDIENTS AND APPEARANCE
    LEMON GLYCERIN 
    glycerin swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63517-160
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN7.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLEMON (Lemon Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63517-160-019 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35608/01/2013
    Labeler - Cardinal Health (097537435)
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