Label: LEMON- glycerin swab

  • NDC Code(s): 68786-160-01, 68786-160-02
  • Packager: Sion Biotext Medical Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 10, 2024

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  • Active Ingredient

    Glycerin 7.5% v/v              

  • Purpose

    Oral Demulcent

  • Warning:

    For Oral Use Only.

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

    Keep out of reach of children.

  • Use

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

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

    • Store at room temperature. 15 ° C- 30 °C (59°F - 86 °F)
    • Avoid excessive heat.
  • Inactive ingredients

    Citric acid, lemon flavor, sodium benzoate, water

  • Principle Display Panel

    25 packets

    3 swabsticks per packet

    Lemon-Glycerin Swabstick

    For Professional and Hospital Use

    Sion Biotext Medical Ltd

    68786-160-02

    Label

    50 packets

    1 swabstick per packet

    Lemon-Glycerin Swabstick

    For Professional and Hospital Use

    Sion Biotext Medical Ltd

    68786-160-01

    Label

  • INGREDIENTS AND APPEARANCE
    LEMON 
    glycerin swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68786-160
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN7.5 mg  in 100 mg
    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:68786-160-0210 in 1 CASE04/11/2013
    125 in 1 BOX
    13 mg in 1 PACKET; Type 0: Not a Combination Product
    2NDC:68786-160-0110 in 1 CASE04/11/2013
    250 in 1 BOX
    21 mg in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02204/11/2013
    Labeler - Sion Biotext Medical Ltd (532775194)
    Registrant - Sion Biotext Medical Ltd (532775194)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sion Biotext Mexico SAPI de CV951575186manufacture(68786-160)
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