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 August 18, 2011

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  • Active Ingredient

    Active Ingredient                                     Purpose

    Glycerin 7.5% v/v                                  Oral Demulcent

  • Use of Lemon Glycerin Swabstick

    Use: Lemon_Glycerin

    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 & USAGE

    Indications and Usage

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

    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

  • Principle Display Panel

    Lemon Glycerin Swabstick

    Lemon_Glycerin

  • INGREDIENTS AND APPEARANCE
    LEMON GLYCERIN 
    glycerin swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-160
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN7.5 mL  in 100 mL
    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:67777-160-0110 in 1 CASE
    150 in 1 BOX
    13 mL in 1 PACKET
    2NDC:67777-160-0210 in 1 CASE
    225 in 1 BOX
    29 mL in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/21/2011
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jiangsu Provonce JianErKang Medical Dressing Co. Ltd.530968767manufacture
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