CHARM TEX- sodium fluoride gel, 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 Fluoride 0.22% (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 accidently swallowed, get medical help or contact a poison control centre immediately.

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

Carbopol, Disodium EDTA, Sodium Hydroxide, Poly Ethylene Glycol-40, Sorbitol, Purified water, Sodium Saccharin, Sodium Lauryl Sulphate, Flavor, Sodium Benzoate.

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. 0.85 OZ
(24 GRAMS)

INGREDIENTS AND APPEARANCE

CHARM TEX 
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 40057-1010
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.22 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 40057-1010-5	7 g in 1 TUBE; Type 0: Not a Combination Product	06/15/2019
2	NDC: 40057-1010-4	17 g in 1 TUBE; Type 0: Not a Combination Product	06/15/2019
3	NDC: 40057-1010-3	24 g in 1 TUBE; Type 0: Not a Combination Product	06/15/2019
4	NDC: 40057-1010-2	43 g in 1 TUBE; Type 0: Not a Combination Product	06/15/2019
5	NDC: 40057-1010-1	78 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(40057-1010)