FDA.reportPublic FDA data

Charm-Tex FLUORIDE Gel

Manufacturer
Jiangsu Aimeili Cosmetic Co.,Ltd.
Effective date
2024-01-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:06:41

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

image descriptionimage description

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77573-012-012026-01-29C16284748780-149896155-d2c2-586f-e063-e6dba90add9077573-012
77573-012-022026-01-29C16284748780-149896155-d2c2-586f-e063-e6dba90add9077573-012
77573-012-032026-01-29C16284748780-149896155-d2c2-586f-e063-e6dba90add9077573-012
77573-012-042026-01-29C16284748780-149896155-d2c2-586f-e063-e6dba90add9077573-012
77573-012-052026-01-29C16284748780-149896155-d2c2-586f-e063-e6dba90add9077573-012
77573-012-062026-01-29C16284748780-149896155-d2c2-586f-e063-e6dba90add9077573-012
77573-012-072026-01-29C16284748780-149896155-d2c2-586f-e063-e6dba90add9077573-012

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77573-012-01Charm-Tex FLUORIDE Gel1000 in 1 PACKAGEPASTE, DENTIFRICE10002
77573-012-01Charm-Tex FLUORIDE Gel7.1 g in 1 TUBEPASTE, DENTIFRICE7.12
77573-012-02Charm-Tex FLUORIDE Gel17 g in 1 TUBEPASTE, DENTIFRICE172
77573-012-02Charm-Tex FLUORIDE Gel720 in 1 PACKAGEPASTE, DENTIFRICE7202
77573-012-03Charm-Tex FLUORIDE Gel24 g in 1 TUBEPASTE, DENTIFRICE242
77573-012-03Charm-Tex FLUORIDE Gel720 in 1 PACKAGEPASTE, DENTIFRICE7202
77573-012-04Charm-Tex FLUORIDE Gel144 in 1 PACKAGEPASTE, DENTIFRICE1442
77573-012-04Charm-Tex FLUORIDE Gel43 g in 1 TUBEPASTE, DENTIFRICE432
77573-012-05Charm-Tex FLUORIDE Gel78 g in 1 TUBEPASTE, DENTIFRICE782
77573-012-05Charm-Tex FLUORIDE Gel144 in 1 PACKAGEPASTE, DENTIFRICE1442
77573-012-06Charm-Tex FLUORIDE Gel130 g in 1 TUBEPASTE, DENTIFRICE1302
77573-012-06Charm-Tex FLUORIDE Gel60 in 1 PACKAGEPASTE, DENTIFRICE602
77573-012-07Charm-Tex FLUORIDE Gel60 in 1 PACKAGEPASTE, DENTIFRICE602
77573-012-07Charm-Tex FLUORIDE Gel181 g in 1 TUBEPASTE, DENTIFRICE1812

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77573-012CHARM-TEX FLUORIDE GEL (SODIUM FLUORIDE) PASTE, DENTIFRICE [JIANGSU AIMEILI COSMETIC CO.,LTD.]2Legacy NDC, 14 package rows20240105_fa04010f-6c5c-4921-a1f7-e1770e9aef12.zip

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
77573-01277573-012-01, 77573-012-02, 77573-012-03, 77573-012-04, 77573-012-05, 77573-012-06, 77573-012-07

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
0e2cfc15-6059-76aa-e063-6394a90a9bf1fa04010f-6c5c-4921-a1f7-e1770e9aef122024-01-05WarningsExact identifier
spl id: 0e2cfc15-6059-76aa-e063-6394a90a9bf1
spl set id: fa04010f-6c5c-4921-a1f7-e1770e9aef12

Reported adverse events (FAERS/openFDA)#

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