CHARM TEX- sodium fluoride gel, dentifrice 
Charm-Tex, Inc. USA.

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 Flouride Gel Toothpaste (DEACTIVATED)

Drug Facts

Active ingredient & Purpose

Active ingredientPurpose
Sodum fluoride 0.22% (0.1 w/v fluoride ion)Anticavity

Use

  • helps protect against cavities.

Warnings

If more than used for brushing is accidently swallowed, get medical help or contact a poison control centre immediately.

Keep out of the reach of children under 6 years of age.

Directions

  • adults and children 6 yrs. 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 physcian

inactive ingredients

Water, Sorbitol, Sodium Lauryl Sulphate, Carbopol, flavor, Sodium Hydroxide, Sodium Saccharin, Disodium EDTA, Sodium benzoate.

Exclusive distributor:

Product of India.


Charm-Tex, Inc. USA.
www.charm-tex.com

Expiry: 2 years from the Date of Mfg.

E.C. No: GUJ/COS/GC/32/1348.

CHARMTEX FLUORIDE GEL TOOTHPASTE

  • TUBE 2.75 OZ (78g) NDC 40057-1010-1
  • TUBE 1.5 OZ (43g) NDC 40057-1010-2
  • TUBE 0.85 OZ (24g) NDC 40057-1010-3
  • TUBE 0.6 OZ (17g) NDC 40057-1010-4
  • SACHET (Pouch) 0.25 OZ (7g) NDC 40057-1010-8
  • TUBE 4.6 OZ (130g) NDC 40057-1010-6
  • TUEB 6.4 OZ (181g) NDC 40057-1010-7

Charm-Tex Gel

CHARM TEX 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40057-1010
Route of AdministrationDENTAL, ORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.22 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
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    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:40057-1010-87 g in 1 POUCH; Type 0: Not a Combination Product06/15/201912/31/2022
2NDC:40057-1010-417 g in 1 TUBE; Type 0: Not a Combination Product06/15/201912/31/2022
3NDC:40057-1010-324 g in 1 TUBE; Type 0: Not a Combination Product06/15/201912/31/2022
4NDC:40057-1010-243 g in 1 TUBE; Type 0: Not a Combination Product06/15/201912/31/2022
5NDC:40057-1010-178 g in 1 TUBE; Type 0: Not a Combination Product06/15/201912/31/2022
6NDC:40057-1010-6130 g in 1 TUBE; Type 0: Not a Combination Product08/18/202112/31/2022
7NDC:40057-1010-7181 g in 1 TUBE; Type 0: Not a Combination Product08/18/202112/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/15/201912/31/2022
Labeler - Charm-Tex, Inc. USA. (058347543)

Revised: 1/2023
Document Id: 06445910-ddd8-2206-e063-6394a90aa519
Set id: 6904e2b7-73d9-455d-b7a9-3288a1f22b7b
Version: 4
Effective Time: 20230101
 
Charm-Tex, Inc. USA.