Fluoride Gel

Manufacturer: Yangzhou Hongshengding Chemical Co.,Ltd.
Effective date: 2018-01-06
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:53:59

Label at a glance#

ProductFluoride Gel

Active ingredientSODIUM FLUORIDE

Label structure6 sections

Indications and uses

helps protect against cavities.

Dosage and administration

Adults and children 2years of age and older:Brush teeth thoroughly,preferably after each meal or at least twice a day,or as directed by a dentist or a physician. Children 2-6 years:Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) Children under 2 years:Ask a dentist or a physician.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.22%(0.15 w/v Fluoride ion)

Purpose

OTC - PURPOSE SECTION

anticavity

Uses

INDICATIONS & USAGE SECTION

helps protect against cavities.

Warnings

WARNINGS SECTION

Keep out of the reach of children under 6 years of age.if more than used for brushing is accidently swallowed,get medical help or contact a Poison Control Center immediately.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2years of age and older:Brush teeth thoroughly,preferably after each meal or at least twice a day,or as directed by a dentist or a physician.

Children 2-6 years:Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)

Children under 2 years:Ask a dentist or a physician.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Sorbitol,Silica,methyl Paraben Sodium,Propyl Paraben Sodium ,Flavour ,Sodium Saccharin,Treated Water,SCMC,Sodium Lauryl Sulfate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
245598	sodium fluoride 0.22 % Toothpaste	PSN	2
245598	sodium fluoride 0.0022 MG/MG Toothpaste	SCD	2
245598	sodium fluoride 0.22 % (fluoride 0.1 % ) Toothpaste	SY	2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71035-400-01	2020-01-31	C162847	48780-1	9d75b9d0-1831-f424-e053-dadaa90a57ce	Charm-Tex Fluoride Gel Toothpaste
71035-400-02	2020-01-31	C162847	48780-1	9d75b9d0-1831-f424-e053-dadaa90a57ce	Charm-Tex Fluoride Gel Toothpaste
71035-400-03	2020-01-31	C162847	48780-1	9d75b9d0-1831-f424-e053-dadaa90a57ce	Charm-Tex Fluoride Gel Toothpaste
71035-400-04	2020-01-31	C162847	48780-1	9d75b9d0-1831-f424-e053-dadaa90a57ce	Charm-Tex Fluoride Gel Toothpaste
71035-400-05	2020-01-31	C162847	48780-1	9d75b9d0-1831-f424-e053-dadaa90a57ce	Charm-Tex Fluoride Gel Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71035-400-01	Fluoride Gel	17 g in 1 TUBE	PASTE	17	2
71035-400-01	Fluoride Gel	720 in 1 BOX	PASTE	720	2
71035-400-02	Fluoride Gel	720 in 1 BOX	PASTE	720	2
71035-400-02	Fluoride Gel	24 g in 1 TUBE	PASTE	24	2
71035-400-03	Fluoride Gel	144 in 1 BOX	PASTE	144	2
71035-400-03	Fluoride Gel	43 g in 1 TUBE	PASTE	43	2
71035-400-04	Fluoride Gel	1000 in 1 BOX	PASTE	1000	2
71035-400-04	Fluoride Gel	0.22 g in 1 TUBE	PASTE	0.22	2
71035-400-05	Fluoride Gel	7 g in 1 TUBE	PASTE	7	2
71035-400-05	Fluoride Gel	1000 in 1 BOX	PASTE	1000	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71035-400	FLUORIDE GEL (SODIUM FLUORIDE) PASTE [YANGZHOU HONGSHENGDING CHEMICAL CO.,LTD.]	2	Legacy NDC, 10 package rows	20180108_3f4d9559-9f18-2552-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Fluoride Gel
Sodium Fluoride
CARBOCYSTEINE LYSINE MONOHYDRATE
SORBITOL
SODIUM LAURYL SULFATE
METHYL PARAOXON
PROPYLPARABEN SODIUM
WATER
SODIUM SILICATE
POTASSIUM SODIUM SACCHARATE
FLUORIDE ION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71035-400	71035-400-01, 71035-400-02, 71035-400-03, 71035-400-04, 71035-400-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CARBOCYSTEINE LYSINE MONOHYDRATE	QA5ZP9OL3E	IACT
SORBITOL	506T60A25R	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
METHYL PARAOXON	UE1A2XL95H	IACT
PROPYLPARABEN SODIUM	625NNB0G9N	IACT
WATER	059QF0KO0R	IACT
SODIUM SILICATE	IJF18F77L3	IACT
POTASSIUM SODIUM SACCHARATE	73U34YC90U	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
62175f7d-6bd8-2fb8-e053-2991aa0adb4b			3f4d9559-9f18-2552-e054-00144ff8d46c	2018-01-06	Warnings	Exact identifier spl id: 62175f7d-6bd8-2fb8-e053-2991aa0adb4b spl set id: 3f4d9559-9f18-2552-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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