DR. FRESH DAILIES TRAVEL- 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.

Administration route:

DENTAL

Prescription type:

OTC DRUG

Therapeutic indications:

helps protect against cavities

Authorization status:

OTC monograph final

Summary of Product characteristics

DR. FRESH DAILIES TRAVEL- 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._
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DR. FRESH DAILIES TRAVEL KIT
DRUG FACTS
ACTIVE INGREDIENT
Sodium Monofluorophosphate 0.76 percent (0.15 percent w v fluoride
ion)
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.
DIRECTIONS
Adults and children 2 years of age and older: Brush teeth thoroughly,
preferably after each meal or
at least twice a day, or as directed by a dentist or physician.
Children under the age of 6: Use only a pea sized amount and supervise
child's brushing and rinsing
(to minimize swallowing)
Children under 2 years of age: Ask a dentist or doctor.
INACTIVE INGREDIENTS
dicalcium phosphate dihydrate, water, glycerin, sodium lauryl sulfate,
cellulose gum, flavor,
tetrasodium pyrophosphate, sodium saccharin
Questions or Comments
Toll Free: 1-866-DR-Fresh (1-866-373-7374) or comments drfresh.com
Visit us online at: www.drfresh.com
Monday-Friday 8:30 am to 5:30 pm
PACKAGE LABELING:
DR. FRESH DAILIES TRAVEL
sodium monofluorophosphate paste
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 48 9 3-220
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 .76 g
in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
DIBASIC CALCIUM PHO SPHATE DIHYDRATE (UNII: O7TSZ9 7GEP)
WATER (UNII: 0 59 QF0 KO0 R)
GLYCERIN (UNII: PDC6 A3C0 OX)
SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)
CARBO XYMETHYLCELLULO SE SO DIUM, UNSPECIFIED FO RM (UNII: K6 79
OBS311)
METHYL SALICYLATE (UNII: LAV5U50 22