CHARM TEX- sodium monofluorophosphate paste, dentifrice 
Charm Tex, Inc.

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.

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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

PRINCIPAL DISPLAY PANEL - 42.5 Grams Tube Label
CHARM TEX 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40057-1000
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) Sodium monofluorophosphate0.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Calcium Carbonate (UNII: H0G9379FGK) 42 g  in 100 g
Sorbitol (UNII: 506T60A25R)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Carboxymethylcellulose Sodium (UNII: K679OBS311)  
Saccharin Sodium Dihydrate (UNII: SB8ZUX40TY)  
Methylparaben Sodium (UNII: CR6K9C2NHK)  
Propylparaben Sodium (UNII: 625NNB0G9N)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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)

Revised: 12/2011
Document Id: 43c0b759-3885-4dcc-8c8c-0a2d9bbc0211
Set id: 760f7965-ee34-486a-b524-f958155cb1f6
Version: 1
Effective Time: 20111229
 
Charm Tex, Inc.