FDA.reportPublic FDA data

Charm-Tex Flouride Gel Toothpaste (HCP)

Manufacturer
Charm-Tex, Inc. USA.
Effective date
2022-01-24
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:11:58

Label at a glance#

ProductCharm Tex
Active ingredientSODIUM FLUORIDE
Label structure7 sections

Dosage and administration

adults and children 6 yrs. of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. children 2 to 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 physcian

Label contents#

Full prescribing information#

Active ingredient & Purpose

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientPurpose
Sodum fluoride 0.22% (0.1 w/v fluoride ion)Anticavity

Use

INDICATIONS & USAGE SECTION

  • helps protect against cavities.

Warnings

WARNINGS SECTION

If more than used for brushing is accidently swallowed, get medical help or contact a poison control centre immediately.

Keep out of the reach of children under 6 years of age.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 6 yrs. of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.
  • children 2 to 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 physcian

inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Sorbitol, Sodium Lauryl Sulphate, Carbopol, flavor, Sodium Hydroxide, Sodium Saccharin, Disodium EDTA, Sodium benzoate.

Exclusive distributor:

SPL UNCLASSIFIED SECTION

Product of India.


Charm-Tex, Inc. USA.
www.charm-tex.com

Expiry: 2 years from the Date of Mfg.

E.C. No: GUJ/COS/GC/32/1348.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CHARMTEX FLUORIDE GEL TOOTHPASTE

  • TUBE 2.75 OZ (78g) NDC 40057-1010-1
  • TUBE 1.5 OZ (43g) NDC 40057-1010-2
  • TUBE 0.85 OZ (24g) NDC 40057-1010-3
  • TUBE 0.6 OZ (17g) NDC 40057-1010-4
  • SACHET (Pouch) 0.25 OZ (7g) NDC 40057-1010-8
  • TUBE 4.6 OZ (130g) NDC 40057-1010-6
  • TUEB 6.4 OZ (181g) NDC 40057-1010-7

Charm-Tex GelCharm-Tex Gel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
40057-1010-12021-08-23C16284748780-1ba0f9c33-45c9-a910-e053-dadaa90a0b85Charm-Tex Flouride Gel Toothpaste (HCP)
40057-1010-22021-08-23C16284748780-1ba0f9c33-45c9-a910-e053-dadaa90a0b85Charm-Tex Flouride Gel Toothpaste (HCP)
40057-1010-32021-08-23C16284748780-1ba0f9c33-45c9-a910-e053-dadaa90a0b85Charm-Tex Flouride Gel Toothpaste (HCP)
40057-1010-42021-08-23C16284748780-1ba0f9c33-45c9-a910-e053-dadaa90a0b85Charm-Tex Flouride Gel Toothpaste (HCP)
40057-1010-52021-08-23C16284748780-1ba0f9c33-45c9-a910-e053-dadaa90a0b85Charm-Tex Flouride Gel Toothpaste (HCP)
40057-1010-12021-01-29C16284748780-1ba0f9c33-45c9-a910-e053-dadaa90a0b85Charm-Tex Flouride Gel Toothpaste (HCP)
40057-1010-22021-01-29C16284748780-1ba0f9c33-45c9-a910-e053-dadaa90a0b85Charm-Tex Flouride Gel Toothpaste (HCP)
40057-1010-32021-01-29C16284748780-1ba0f9c33-45c9-a910-e053-dadaa90a0b85Charm-Tex Flouride Gel Toothpaste (HCP)
40057-1010-42021-01-29C16284748780-1ba0f9c33-45c9-a910-e053-dadaa90a0b85Charm-Tex Flouride Gel Toothpaste (HCP)
40057-1010-52021-01-29C16284748780-1ba0f9c33-45c9-a910-e053-dadaa90a0b85Charm-Tex Flouride Gel Toothpaste (HCP)

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
40057-101040057-1010-8, 40057-1010-4, 40057-1010-3, 40057-1010-2, 40057-1010-1, 40057-1010-6, 40057-1010-7

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
NameUNIIKind
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
SODIUM HYDROXIDE55X04QC32IIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB

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
06445910-ddd8-2206-e063-6394a90aa5196904e2b7-73d9-455d-b7a9-3288a1f22b7b2023-01-01WarningsExact identifier
spl set id: 6904e2b7-73d9-455d-b7a9-3288a1f22b7b

Reported adverse events (FAERS/openFDA)#

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