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 May 25, 2023

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

View All Sections
  • Active Ingredient

    Glycerin 7.5% v/v

  • Purpose

    Oral Demulcent

  • Uses:

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

  • Warnings:

    For oral use only. Do not get in eyes.

  • Do not use:

    • If you are allergic to any of the ingredients.
    • On children under 2 years of age unless directed by a doctor or dentist.
  • Stop use and ask a doctor if:

    • Sore throat is severe, persists for more than 2 days, and is accompanied or followed by fever, headache, rash, nausea, or vomiting
    • Sore mouth symptoms do not improve in 7 days.
  • Keep out of reach of children:

    In case of overdose, get medicl help or contact a Poison Control Center right away.

  • Directions:

    Adults and children 12 years of age and older: Tear open the packet and remove the swabstick. Swab around the mouth and discard. Use as needed or as directed by a dentist or doctor. Children under 12 years of age should be supervised in the use of this product.

  • Other information

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

    Citric acid, Lemon flavor, Sodium benzoate, Water

  • Principle Display Panel

    PROCURE

    HEALTHCARE PRODUCTS

    Triple Pack

    LEMON

    GLYCERIN

    SWABSTICKS

    Oral Demulcent

    temporary relief

    of minor discomfort

    and protection of

    irritated areas in

    sore mouth and

    sore throat

    FOR ORAL USE ONLY

    25 PACKS

    132

  • INGREDIENTS AND APPEARANCE
    LEMON 
    glycerin swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55681-750
    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:55681-750-0010 in 1 CASE05/25/2023
    125 in 1 BOX
    10.3 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35605/25/2023
    Labeler - TwinMed LLC (009579330)
    Registrant - TwinMed LLC (009579330)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sion Biotext Mexico SAPI de CV951575186manufacture(55681-750)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!