FDA.reportPublic FDA data

42086-001 Charm Tex FLUORIDE Tooth paste SODIUM MONOFLUOROPHOSPHATE

Manufacturer
Jiangsu Gold Worldworks Household Chemicals Co., Ltd.
Effective date
2026-05-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-06-03 18:03:33

Label at a glance#

ProductCharm Tex FLUORIDE
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure7 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#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

SODIUM MONOFLUOROPHOSPHATE: 0.76% (0.1% Fluoride ion)

OTC - PURPOSE SECTION

Purpose: 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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

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
42086-05142086-051-01, 42086-051-02, 42086-051-03, 42086-051-04, 42086-051-05, 42086-051-06

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 MONOFLUOROPHOSPHATEC810JCZ56QACTIM

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 FLUORIDESODIUM MONOFLUOROPHOSPHATEJiangsu Gold Worldworks Household Chemicals Co., Ltd.2bddc69a-0c0f-47fc-bc98-90c2ec70dd6f2026-05-31WarningsExact identifier
ndc (package): 42086-051-03
ndc (package): 42086-051-02
ndc (package): 42086-051-04
ndc (package): 42086-051-06
ndc (package): 42086-051-05
ndc (package): 42086-051-01
ndc (product): 42086-051
ndc11 (package): 42086005106
ndc11 (package): 42086005105
ndc11 (package): 42086005104
ndc11 (package): 42086005103
ndc11 (package): 42086005102
ndc11 (package): 42086005101
spl id: 53169607-6939-663b-e063-6394a90a082b
spl set id: 2bddc69a-0c0f-47fc-bc98-90c2ec70dd6f

Reported adverse events (FAERS/openFDA)#

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