Active Ingredient

Glycerin 7.5% v/v

Purpose

Oral Demulcent

Warning:

For Oral Use Only.

Do not get in eyes.

Keep out of reach of children.

Use

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

Directions

Swab mouth as needed.
Discard after single use.
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

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

Inactive ingredients

Citric acid, lemon flavor, sodium benzoate, water

Principle Display Panel

25 packets

3 swabsticks per packet

Lemon-Glycerin Swabstick

For Professional and Hospital Use

Sion Biotext Medical Ltd

68786-160-02

Label

50 packets

1 swabstick per packet

Lemon-Glycerin Swabstick

For Professional and Hospital Use

Sion Biotext Medical Ltd

68786-160-01

Label

LEMON
glycerin swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68786-160
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	7.5 mg in 100 mg

Ingredient Name	Strength
Inactive Ingredients
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68786-160-02	10 in 1 CASE	04/11/2013
1		25 in 1 BOX
1		3 mg in 1 PACKET; Type 0: Not a Combination Product
2	NDC:68786-160-01	10 in 1 CASE	04/11/2013
2		50 in 1 BOX
2		1 mg in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M022	04/11/2013

Labeler - Sion Biotext Medical Ltd (532775194)

Registrant - Sion Biotext Medical Ltd (532775194)

Name	Address	ID/FEI	Business Operations
Establishment
Sion Biotext Mexico SAPI de CV		951575186	manufacture(68786-160)

Lemon Glycerin Swabsticks