CHARM TEX- sodium monofluorophosphate paste, dentifrice

Charm Tex by

Drug Labeling and Warnings

Charm Tex by is a Otc medication manufactured, distributed, or labeled by Charm Tex, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

CHARM TEX 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 40057-1000
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O)	Sodium monofluorophosphate	0.76 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 40057-1000-1	141 g in 1 TUBE
2	NDC: 40057-1000-2	85 g in 1 TUBE
3	NDC: 40057-1000-3	42.5 g in 1 TUBE
4	NDC: 40057-1000-4	24 g in 1 TUBE
5	NDC: 40057-1000-5	17 g in 1 TUBE
6	NDC: 40057-1000-6	4.24 g in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	06/01/2011

Labeler - Charm Tex, Inc. (058347543)