LEMON GLYCERIN - glycerin swab 
Dynarex Corporation

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.

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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.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Indications and Usage

Directions

Administration

Dosage

Other information

Other information:

Inactive ingredients:

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

Principle Display Panel

Lemon Glycerin Swabstick

Lemon_Glycerin

LEMON GLYCERIN 
glycerin swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-160
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN7.5 mL  in 100 mL
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:67777-160-0110 in 1 CASE
150 in 1 BOX
13 mL in 1 PACKET
2NDC:67777-160-0210 in 1 CASE
225 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/FEIBusiness Operations
Jiangsu Provonce JianErKang Medical Dressing Co. Ltd.530968767manufacture

Revised: 8/2011
Document Id: 4385d760-1b33-4570-82d6-7fec76a38b34
Set id: 376fe9be-0154-4609-8927-4088da559fe7
Version: 3
Effective Time: 20110818
 
Dynarex Corporation