charm-tex fluoride gel toothpaste 73343-002

charm-tex fluoride gel toothpaste 73343-002
SPL v1
SPL
SPL Set ID 94df04cc-a430-c57a-e053-2995a90a7fb4
Route
dental
Published
Effective Date 2016-05-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.22 g)
Inactive Ingredients
carbocysteine lysine monohydrate sorbitol sodium lauryl sulfate methyl paraoxon propylparaben sodium water sodium silicate potassium sodium saccharate

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2019-10-14
Purpose

anticavity

Description

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

Medication Information

Warnings

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.

Uses

helps protect against cavities.

Purpose

anticavity

Directions

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.

Description

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

Section 50565-1

Keep out of reach of children.

Section 51945-4

Active Ingredients

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

Inactive Ingredient

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

Structured Label Content

Warnings

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.

Uses

helps protect against cavities.

Purpose

anticavity

Directions

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.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

Active Ingredients (Active ingredients)

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

Inactive Ingredient (INACTIVE INGREDIENT)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:52.966921 · Updated: 2026-03-14T22:55:39.728866