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NDC 68786-0160-01 Lemon 7.5 1/1 Details

Lemon 7.5 1/1

Lemon is a ORAL SWAB in the HUMAN OTC DRUG category. It is labeled and distributed by Sion Biotext Medical Ltd. The primary component is GLYCERIN.

Product Information

NDC	68786-0160
Product ID	68786-160_d4b2adb9-a952-374c-e053-2995a90ac6c8
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Lemon
Proprietary Name Suffix	n/a
Non-Proprietary Name	Glycerin
Product Type	HUMAN OTC DRUG
Dosage Form	SWAB
Route	ORAL
Active Ingredient Strength	7.5
Active Ingredient Units	1/1
Substance Name	GLYCERIN
Labeler Name	Sion Biotext Medical Ltd
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part356
Listing Certified Through	2023-12-31

Package

Package Images

NDC 68786-0160-01 (68786016001)

Pricing Information	N/A
NDC Package Code	68786-160-01
Billing NDC	68786016001
Package	10 BOX in 1 CASE (68786-160-01) / 50 PACKET in 1 BOX / 1 SWAB in 1 PACKET
Marketing Start Date	2013-04-11
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL dbd7ed86-1b92-4471-827a-89f3afa1b0dc Details

Active Ingredient

Glycerin 7.5% v/v

Purpose

Oral Demulcent

Warning:

For Oral Use Only.

Do not get in eyes.

SPL UNCLASSIFIED SECTION

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

50 packets

1 swabstick per packet

Lemon-Glycerin Swabstick

For Professional and Hospital Use

Sion Biotext Medical Ltd

68786-160-01

INGREDIENTS AND APPEARANCE

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

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 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 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 not final	part356	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)

Revised: 1/2022

Document Id: d4b2adb9-a952-374c-e053-2995a90ac6c8

Set id: dbd7ed86-1b92-4471-827a-89f3afa1b0dc

Version: 5

Effective Time: 20220103