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Lemon Glycerin by Dynarex Corporation

Dosage form: swab
Ingredients: GLYCERIN 7.5mL in 100mL
Labeler: Dynarex Corporation
NDC Code: 67777-160

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.

Lemon Glycerin Swabsticks

Active Ingredient

Active Ingredient                                     Purpose

Glycerin 7.5% v/v                                  Oral Demulcent

Use of Lemon Glycerin Swabstick

Use: Lemon_Glycerin

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

Warnings

Warning:

For Oral Use Only.

  • Do not get in eyes.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Indications and Usage

  • For temporary relief of minor soreness and/or irritation of the mouth.
  • Dry mouth relief.

Directions

Administration

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

  • 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 deg - 30 deg C, 58 deg - 86 deg F
  • Avoid excessive heat.

Inactive ingredients:

Inactive ingredients: Citric acid, lemon flavor, sodium benzoate, water

Principle Display Panel

Lemon Glycerin Swabstick

LEMON GLYCERIN 
glycerin swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-160
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (GLYCERIN) GLYCERIN7.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BENZOATE 
CITRIC ACID MONOHYDRATE 
WATER 
Product Characteristics
Color    Score    
ShapeSize
FlavorLEMON (Lemon Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:67777-160-0110 BOX (BOX) in 1 CASE
150 PACKET (PACKET) in 1 BOX
13 mL in 1 PACKET
2NDC:67777-160-0210 BOX (BOX) in 1 CASE
225 PACKET (PACKET) in 1 BOX
29 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/21/2011
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)
Establishment
NameAddressID/FEIOperations
Jiangsu Provonce JianErKang Medical Dressing Co. Ltd.530968767manufacture

Revised: 08/2011
 
Dynarex Corporation

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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