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NDC 68121-0174-02 Morning Fresh 2.2 mg/g Details

Morning Fresh 2.2 mg/g

Morning Fresh is a ORAL PASTE in the HUMAN OTC DRUG category. It is labeled and distributed by Patcos Cosmetics (India) Private Limited. The primary component is SODIUM FLUORIDE.

MedlinePlus Drug Summary

Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usually is prescribed for children and adults whose homes have water that is not fluoridated (already has fluoride added). This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 68121-0174-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fluoride

Product Information

NDC	68121-0174
Product ID	68121-174_6068c895-4855-9246-e053-2a91aa0a6b67
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Morning Fresh
Proprietary Name Suffix	n/a
Non-Proprietary Name	Sodium Fluoride
Product Type	HUMAN OTC DRUG
Dosage Form	PASTE
Route	ORAL
Active Ingredient Strength	2.2
Active Ingredient Units	mg/g
Substance Name	SODIUM FLUORIDE
Labeler Name	Patcos Cosmetics (India) Private Limited
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part355
Listing Certified Through	2022-12-31

Package

Package Images

NDC 68121-0174-02 (68121017402)

Pricing Information	N/A
NDC Package Code	68121-174-02
Billing NDC	68121017402
Package	78 g in 1 TUBE (68121-174-02)
Marketing Start Date	2014-05-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 836d85a9-1008-4d3d-9a80-6ea4262ab9bd Details

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

INGREDIENTS AND APPEARANCE

MORNING FRESH

sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68121-174
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2.2 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68121-174-01	43 g in 1 TUBE; Type 0: Not a Combination Product	05/14/2014
2	NDC:68121-174-02	78 g in 1 TUBE; Type 0: Not a Combination Product	05/14/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	05/14/2014

Labeler - Patcos Cosmetics (India) Private Limited (916169451)

Name	Address	ID/FEI	Business Operations
Establishment
Patcos Cosmetics (India) Private Limited		675973979	manufacture(68121-174)

Revised: 12/2017

Document Id: 6068c895-4855-9246-e053-2a91aa0a6b67

Set id: 836d85a9-1008-4d3d-9a80-6ea4262ab9bd

Version: 3

Effective Time: 20171215