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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Active Ingredient

Active Ingredient Purpose

Glycerin 7.5% v/v Oral Demulcent

Use of Lemon Glycerin Swabstick

Use:

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

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

LEMON GLYCERIN
glycerin swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67777-160
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (GLYCERIN)	GLYCERIN	7.5 mL in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM BENZOATE
CITRIC ACID MONOHYDRATE
WATER

Product Characteristics
Color		Score
Shape		Size
Flavor	LEMON (Lemon Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:67777-160-01	10 BOX ( BOX) in 1 CASE	contains a BOX
1		50 PACKET ( PACKET) in 1 BOX	This package is contained within the CASE (67777-160-01) and contains a PACKET
1		3 mL in 1 PACKET	This package is contained within a BOX and a CASE (67777-160-01)
2	NDC:67777-160-02	10 BOX ( BOX) in 1 CASE	contains a BOX
2		25 PACKET ( PACKET) in 1 BOX	This package is contained within the CASE (67777-160-02) and contains a PACKET
2		9 mL in 1 PACKET	This package is contained within a BOX and a CASE (67777-160-02)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	06/21/2011

Labeler - Dynarex Corporation (008124539)

Registrant - Dynarex Corporation (008124539)

Revised: 06/2011 Dynarex Corporation