DR. FRESH ORAL CARE- sodium monofluorophosphate paste

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)

Available from:

Dr. Fresh, Inc

INN (International Name):

SODIUM MONOFLUOROPHOSPHATE

Composition:

SODIUM MONOFLUOROPHOSPHATE 0.76 g in 100 g

Administration route:

DENTAL

Prescription type:

OTC DRUG

Therapeutic indications:

helps protect against cavities.

Authorization status:

OTC monograph final

Summary of Product characteristics

DR. FRESH ORAL CARE- SODIUM MONOFLUOROPHOSPHATE PASTE
DR. FRESH, INC
_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._
----------
DR. FRESH ORAL CARE KIT
DRUG FACTS
ACTIVE INGREDIENT
Sodium Monofluorophosphate (0.76%)
PURPOS E
Anticavity
US E
helps protect against cavities.
WARNINGS
KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS OF AGE.
If more than used for brushing is accidentally swallowed, get medical
help or contact a Poison Control
Center right away.
INACTIVE INGREDIENTS
Calcium Carbonate, Carboxymethyl Cellulose, Flavor, Glycerin, Hydrated
Silica, Sodium Benzoate,
Sodium Lauryl Sulphate, Sodium Saccharin, Sorbitol, Tetrasodium
Pyrophosphate, Water.
DIRECTIONS
Adults and children 2 years of age and older: brush teeth thoroughly
after meals or at least twice a
day as directed by a dentist or physician. Do not swallow.
To minimize swallowing use a pea-sized amount in children under 6.
Supervise children's brushing until good habits are established.
Children under 2 years: ask a dentist.
FOR CLEAN AND HEALTHY TEETH: See your dentist on a regular basis for a
professional cleaning. Use
dental floss daily.
QUESTIONS OR COMMENTS?
Call toll-free 1-866-373-7374 or visit us at www.drfresh.com and
www.binaca.com
PACKAGE LABELING:
DR. FRESH ORAL CARE
sodium monofluorophosphate paste
Dr. Fresh, Inc
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 48 9 3-320
ROUTE OF ADMINISTRATION
DENTAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRE NG TH
STRE NG TH
SO DIUM MO NO FLUO RO PHO SPHATE (UNII: C8 10 JCZ56 Q) (FLUORIDE ION -
UNII:Q8 0 VPU40 8 O)
FLUORIDE ION
0 .15 g
in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
CALCIUM CARBO NATE (UNII: H0 G9 379 FGK)
GLYCERIN (UNII: PDC6 A3C0 OX)
SO DIUM BENZO ATE (UNII: OJ245FE5EU)
SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)
SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)
SO RBITO L (UNII: 50