MORNING FRESH- sodium fluoride paste 
Patcos Cosmetics (India) Private Limited

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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Toothpaste

Active Ingredient

Sodium Fluoride 0.22 %

Purpose: Anticavity

Use

Inactive Ingredient

Calcium carbonate, Carboxymethycellulose sodium, Flavour, Hydrated silica,Potassium nitrate,  Purified water, Saccharin sodium, Sodium benzoate, Sodium lauryl sulfate, Sorbitol

Dosage and Administration

Directions:

Indications and Usage

Warnings

Keep out of reach of children.

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

Principal Display Panel

Patcos Toothpaste

Patcos Toothpaste 1.jpg

Patcos Toothpaste

MORNING FRESH 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68121-174
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.2 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
WATER (UNII: 059QF0KO0R)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
POTASSIUM NITRATE (UNII: RU45X2JN0Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68121-174-0143 g in 1 TUBE; Type 0: Not a Combination Product05/14/2014
2NDC:68121-174-0278 g in 1 TUBE; Type 0: Not a Combination Product05/14/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/14/2014
Labeler - Patcos Cosmetics (India) Private Limited (916169451)
Establishment
NameAddressID/FEIBusiness Operations
Patcos Cosmetics (India) Private Limited675973979manufacture(68121-174)

Revised: 12/2017
Document Id: 6068c895-4855-9246-e053-2a91aa0a6b67
Set id: 836d85a9-1008-4d3d-9a80-6ea4262ab9bd
Version: 3
Effective Time: 20171215
 
Patcos Cosmetics (India) Private Limited