MORNING FRESH- sodium fluoride paste

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)

Available from:

Patcos Cosmetics (India) Private Limited

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Use - Aids in the prevention of dental cavities. - The prevention of dental cavities.

Authorization status:

OTC monograph final

Summary of Product characteristics

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._
----------
TOOTHPAS TE
ACTIVE INGREDIENT
Sodium Fluoride 0.22 %
PURPOSE: ANTICAVITY
US E
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 T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 8 121-174
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
SO DIUM FLUO RIDE (UNII: 8 ZYQ1474W7) (FLUORIDE ION - UNII:Q8 0 VPU40
8 O)
FLUORIDE ION
2.2 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
SO RBITO L (UNII: 50 6 T6 0 A25R)
HYDRATED SILICA (UNII: Y6 O7T4G8 P9 )
CALCIUM CARBO NATE (UNII: H0 G9 379 FGK)
Patcos Cosmetics (India) Private Limited
SO DIUM BENZO ATE (UNII: OJ245FE5EU)
SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)
WATER (UNII: 0 59 QF0 KO0 R)
CARBO XYMETHYLCELLULO SE SO DIUM (UNII: K6 79 OBS311)
SO DIUM LAURYL SULFATE