Label: LEMON GLYCERIN- glycerin swab

  • NDC Code(s): 67777-161-10, 67777-161-11
  • Packager: Dynarex Corporation
  • 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 23, 2023

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  • Active Ingredient

    Glycerin 7.5%

  • Purpose

    Oral Demulcent.

  • Use(s)

    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 imrpove in 7 days

    Keep out of reach of children

    If swallowed, or in case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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. Childern under 12 years of age should be supervised in the use of this product.

  • Other information

    • Store at room temperature 15º-30ºC (59º-86ºF)

    • Avoid excessive heat

  • Inactive ingredients

    Citric Acid, Lemon Flavor, Sodium Benzoate, Water

  • Questions?

    1-888-DYNAREX Monday - Friday, 9AM - 5PM EST

  • Label

    1216 BX MASTER1216 Lemon-Glycerin Swabstick

  • 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
    1NDC:67777-161-1125 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)
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