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. USA.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sodium monofluorophosphate - 0.76% (0.1% w/v fluoride ion)

PURPOSE

Anticavity.

USE

Helps protect against cavities.

WARNINGS

Keep out of the reach of children under 6 years of age. If more than used for brushing, is accidentally swallowed, get medical help or contact a Poison Control Center right away.

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 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.

INACTIVE INGREDIENTS

Purified Water, Sorbitol, Calcium Carbonate, Flavor, Sodium Lauryl Sulphate, Sodium Saccharin, Silica, Sodium Carboxy Methyl Cellulose, Sodium Methyl Paraben, Sodium Propyl Paraben, Titanium Dioxide, Xanthan Gum.

Keep out of reach of children under 6 years of age

Keep out of reach of children under 6 years of age

Product of India

Exclusive Distributor:
Charm-Tex, Inc. USA.
1618, Coney Island, Brooklyn,
New York City 11230.

Expires: 2 years from the Date of Mfg.

E.C. No: GUJ/COS/GC/32/1374.
Mfg.Date & Batch No. on Crimp.

May 2019

PRINCIPAL DISPLAY PANEL

Principal Display Panel

Tube Label

Charm-Tex

ANTICAVITY FLUORIDE TOOTHPASTE
NET WT. 0.6 OZ
(17 GRAMS)

INGREDIENTS AND APPEARANCE

CHARM TEX 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 40057-1011
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.76 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
CALCIUM CARBONATE (UNII: H0G9379FGK)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 40057-1011-1	17 g in 1 TUBE; Type 0: Not a Combination Product	06/15/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	06/15/2019

Labeler - Charm-Tex, Inc. USA. (058347543)

Establishment
Name	Address	ID/FEI	Business Operations
Orchid Lifesciences		675474890	manufacture(40057-1011)