Zohar Anti Cavity Mouthwash Bubble Gum Flavour

Manufacturer: ZOHAR KOSHER LIMITED
Effective date: 2024-02-27
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 00:09:51

Label at a glance#

ProductZohar Anti Cavity Mouthwash Bubble Gum Flavour

Active ingredientSODIUM FLUORIDE

Label structure6 sections

Dosage and administration

Adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste vigorously swish 10 ml (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out do not swallow the rinse do not eat or drink for 30 minutes after rinsing instruct children under 12 years of age in good rinsing habits (to minimize swallowing) supervise children as necessary untill capable of...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years of age and older:
use once a day after brushing your teeth with a toothpaste
vigorously swish 10 ml (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
do not swallow the rinse
do not eat or drink for 30 minutes after rinsing
instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
supervise children as necessary untill capable of using without supervision.
Children under 6 years of age: consult a dentist or doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Xylitol, Glycerin, Sodium Benzoate, Flavor, Sodium Citrate, Sodium Saccharin, Citric Acid, Poloxamer 407, FD&C Red #40.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Front Label.jpgBack Label.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
240698	sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse	PSN	1
240698	sodium fluoride 0.5 MG/ML Mouthwash	SCD	1
240698	sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse	SY	1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84045-002-00	Zohar Anti Cavity Mouthwash Bubble Gum Flavour	250 mL in 1 BOTTLE	LIQUID	250		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
84045-002	ZOHAR ANTI CAVITY MOUTHWASH BUBBLE GUM FLAVOUR (SODIUM FLUORIDE) LIQUID [ZOHAR KOSHER LIMITED]	1	1 package rows	20240316_bc8e0859-8be2-470b-800b-b6339a0ff6f8.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

Zohar Anti Cavity Mouthwash Bubble Gum Flavour
SODIUM FLUORIDE
WATER
XYLITOL
GLYCERIN
SODIUM BENZOATE
SODIUM CITRATE
SACCHARIN SODIUM
CITRIC ACID MONOHYDRATE
POLOXAMER 407
FD&C RED NO. 40
FLUORIDE ION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
84045-002	84045-002-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
XYLITOL	VCQ006KQ1E	IACT
GLYCERIN	PDC6A3C0OX	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
1263046b-890d-4f2b-e063-6294a90a0b47			bc8e0859-8be2-470b-800b-b6339a0ff6f8	2024-02-27	Warnings	Exact identifier spl id: 1263046b-890d-4f2b-e063-6294a90a0b47 spl set id: bc8e0859-8be2-470b-800b-b6339a0ff6f8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.