Label: LEMON- glycerin swab

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 January 3, 2022

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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 
    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 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:68786-160-0110 in 1 CASE04/11/2013
    250 in 1 BOX
    21 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35604/11/2013
    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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