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Morning Fresh by Patcos Cosmetics (India) Private Limited

Medically reviewed on December 15, 2017

Dosage form: paste
Ingredients: SODIUM FLUORIDE 2.2mg in 1g
Labeler: Patcos Cosmetics (India) Private Limited
NDC Code: 68121-174

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.

Toothpaste

Active Ingredient

Sodium Fluoride 0.22 %

Purpose: Anticavity

Use

  • Aids in the prevention of dental cavities.

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:

  • Adults and children 2 years and older Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician.
  • Children under 6 years To minimize swallowing, use a pea sized amount and supervise brushing until good habits are established.
  • Children under 2 years Ask a dentist or physician.

Indications and Usage
  • The prevention of dental cavities.

Warnings

  • If you accidentally swallow more than used for brushing, seek professional assistance or contact a Poison Control Center immediately.

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

MORNING FRESH 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68121-174
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION2.2 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
HYDRATED SILICA 
CALCIUM CARBONATE 
SODIUM BENZOATE 
SACCHARIN SODIUM 
WATER 
CARBOXYMETHYLCELLULOSE SODIUM 
SODIUM LAURYL SULFATE 
POTASSIUM NITRATE 
Packaging
#Item CodePackage Description
1NDC:68121-174-0143 g in 1 TUBE
2NDC:68121-174-0278 g in 1 TUBE
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/FEIOperations
Patcos Cosmetics (India) Private Limited675973979manufacture(68121-174)

 
Patcos Cosmetics (India) Private Limited

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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