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Charm Tex by Charm Tex, Inc.

Medically reviewed on December 29, 2017

Dosage form: paste, dentifrice
Ingredients: Sodium monofluorophosphate 0.76g in 100g
Labeler: Charm Tex, Inc.
NDC Code: 40057-1000

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Charm-Tex
FLUORIDE TOOTHPASTE

DRUG FACTS

Active ingredient

Sodium monofluorophosphte 0.76% (0.1% w/v fluoride ion)

Purpose

Anticavity

Use

helps protect against cavities.

Warning

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 centre immediately.

Inactive ingredient

Sorbitol, Silica, Calcium Carbonate, Methyl Paraben Sodium, Propyl Paraben Sodium, Flavour, Sodium Saccharin,Treated water, SCMC, Sodium Lauryl Sulfate.

Directions

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 child's brushing and rinsing to minimize swallowing.

Children under 2 years

Ask a dentist or physician.

Exclusive Distributor: Charm-Tex, Inc. USA

PRINCIPAL DISPLAY PANEL - 42.5 Grams Tube Label

Charm-Tex

FLUORIDE TOOTHPASTE

Net Wt. 1.5 oz.
42.5 Grams

CHARM TEX 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40057-1000
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium monofluorophosphate (Fluoride Ion) Sodium monofluorophosphate0.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Calcium Carbonate42 g  in 100 g
Sorbitol 
Silicon Dioxide 
Sodium Lauryl Sulfate 
Carboxymethylcellulose Sodium 
Saccharin Sodium Dihydrate 
Methylparaben Sodium 
Propylparaben Sodium 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:40057-1000-1141 g in 1 TUBE
2NDC:40057-1000-285 g in 1 TUBE
3NDC:40057-1000-342.5 g in 1 TUBE
4NDC:40057-1000-424 g in 1 TUBE
5NDC:40057-1000-517 g in 1 TUBE
6NDC:40057-1000-64.24 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35506/01/2011
Labeler - Charm Tex, Inc. (058347543)

 
Charm Tex, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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