FDA.reportPublic FDA data

Charm Tex FLUORIDE Gel

Manufacturer
Yangzhou Hongshengding Chemical Co.,Ltd.
Effective date
2025-08-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:09:48

Label at a glance#

ProductCharm Tex FLUORIDE Gel
Active ingredientSODIUM FLUORIDE
Label structure6 sections

Indications and uses

Help protect against cavities.

Dosage and administration

Adults and children 6 years 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 to 6 years: Use only a pea sized amount and supervise children's brushing and rinsing to minimize swallowing Children under 2 years: Ask a dentist or physician

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.22%(0.1 w/v Fluoride Ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Uses

INDICATIONS & USAGE SECTION

Help 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 6 years 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 to 6 years: Use only a pea sized amount and supervise children's brushing and rinsing to minimize swallowing
  • Children under 2 years: Ask a dentist or physician

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Sorbitol, Silica, Calcium Carbonate, Methylparaben Sodium, Propylparaben Sodium, Flavor, Sodium Saccharin, Water,  SCMC, Sodium Lauryl Sulfate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
245598sodium fluoride 0.22 % ToothpastePSN2
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD2
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71035-002-01Charm Tex FLUORIDE Gel1000 in 1 PACKAGEPASTE, DENTIFRICE10002
71035-002-01Charm Tex FLUORIDE Gel7.1 g in 1 TUBEPASTE, DENTIFRICE7.12
71035-002-02Charm Tex FLUORIDE Gel17 g in 1 TUBEPASTE, DENTIFRICE172
71035-002-02Charm Tex FLUORIDE Gel720 in 1 PACKAGEPASTE, DENTIFRICE7202
71035-002-03Charm Tex FLUORIDE Gel24 g in 1 TUBEPASTE, DENTIFRICE242
71035-002-03Charm Tex FLUORIDE Gel720 in 1 PACKAGEPASTE, DENTIFRICE7202
71035-002-04Charm Tex FLUORIDE Gel43 g in 1 TUBEPASTE, DENTIFRICE432
71035-002-04Charm Tex FLUORIDE Gel144 in 1 PACKAGEPASTE, DENTIFRICE1442
71035-002-05Charm Tex FLUORIDE Gel78 g in 1 TUBEPASTE, DENTIFRICE782
71035-002-05Charm Tex FLUORIDE Gel144 in 1 PACKAGEPASTE, DENTIFRICE1442
71035-002-06Charm Tex FLUORIDE Gel130 g in 1 TUBEPASTE, DENTIFRICE1302
71035-002-06Charm Tex FLUORIDE Gel60 in 1 PACKAGEPASTE, DENTIFRICE602
71035-002-07Charm Tex FLUORIDE Gel181 g in 1 TUBEPASTE, DENTIFRICE1812
71035-002-07Charm Tex FLUORIDE Gel60 in 1 PACKAGEPASTE, DENTIFRICE602

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71035-00271035-002-01, 71035-002-02, 71035-002-03, 71035-002-04, 71035-002-05, 71035-002-06, 71035-002-07

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
NameUNIIKind
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM LAURYL SULFATE368GB5141JIACT
CALCIUM CARBONATEH0G9379FGKIACT
WATER059QF0KO0RIACT
METHYLPARABEN SODIUMCR6K9C2NHKIACT
PROPYLPARABEN SODIUM625NNB0G9NIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Charm Tex FLUORIDE GelSODIUM FLUORIDEYangzhou Hongshengding Chemical Co.,Ltd.897b0102-1c96-4699-908e-a7b7e26cd29f2025-08-08WarningsExact identifier
ndc (package): 71035-002-01
ndc (package): 71035-002-03
ndc (package): 71035-002-02
ndc (package): 71035-002-07
ndc (package): 71035-002-05
ndc (package): 71035-002-04
ndc (package): 71035-002-06
ndc (product): 71035-002
ndc11 (package): 71035000204
ndc11 (package): 71035000207
ndc11 (package): 71035000205
ndc11 (package): 71035000206
ndc11 (package): 71035000202
ndc11 (package): 71035000203
ndc11 (package): 71035000201
spl id: 3bd5bb42-2961-722f-e063-6394a90ae635
spl set id: 897b0102-1c96-4699-908e-a7b7e26cd29f

Reported adverse events (FAERS/openFDA)#

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