LEMON- glycerin swab 
Sion Biotext Medical Ltd

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

Glycerin 7.5% v/v              

Purpose

Oral Demulcent

Warning:

For Oral Use Only.

Keep out of reach of children.

Use

Directions

Other information

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:68786-160
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN7.5 
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:68786-160-0210 in 1 CASE04/11/2013
125 in 1 BOX
13 in 1 PACKET; Type 0: Not a Combination Product
2NDC:68786-160-0110 in 1 CASE04/11/2013
250 in 1 BOX
21 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35604/11/2013
Labeler - Sion Biotext Medical Ltd (532775194)
Registrant - Sion Biotext Medical Ltd (532775194)
Establishment
NameAddressID/FEIBusiness Operations
Sion Biotext Mexico SAPI de CV951575186manufacture(68786-160)

Revised: 1/2022
Document Id: d4b2adb9-a952-374c-e053-2995a90ac6c8
Set id: dbd7ed86-1b92-4471-827a-89f3afa1b0dc
Version: 5
Effective Time: 20220103
 
Sion Biotext Medical Ltd