Label: LEMON GLYCERIN- 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

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Glycerin 7.5% v/v                               

  • Purpose

    Oral Demulcent

  • Uses

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

    For Oral Use Only

    Do not get in eyes

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • 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

    Other information:

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

    Citric acid, lemon flavor, sodium benzoate, water

  • Principle Display Panel

    NDC 67777-161-10

    Lemon - Glycerin Swabsticks

    For Professional and Hospital Use.

    25 Packets

    3 swabsticks per packet

    Label

  • INGREDIENTS AND APPEARANCE
    LEMON GLYCERIN 
    glycerin swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-161
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.3 g  in 4 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:67777-161-10250 in 1 CASE12/18/2019
    125 in 1 BOX
    10.3 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35612/18/2019
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sion Biotext Mexico SAPI de CV951575186manufacture(67777-161)