COLGATE ESSENTIALS- sodium monofluorophosphate paste, dentifrice

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mission Hills S.A de C.V

INN (International Name):

SODIUM MONOFLUOROPHOSPHATE

Composition:

FLUORIDE ION 1.0 mg in 1 g

Administration route:

DENTAL

Prescription type:

OTC DRUG

Therapeutic indications:

Anticavity helps protect against cavities

Authorization status:

OTC monograph not final

Summary of Product characteristics

COLGATE ESSENTIALS- SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE
MISSION HILLS S.A DE C.V
_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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COLGATE ESSENTIALS™ TOOTHPASTE
_DRUG FACTS_
ACTIVE INGREDIENT
Sodium monofluorophosphate 0.76% (0.10% 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 2 to 6
years
use only a pea sized amount and
supervise child's brushing and rinsing
(to minimize swallowing)
children under 2
years
ask a dentist or physician
INACTIVE INGREDIENTS
water, hydrated silica, sorbitol, calcium pyrophosphate, glycerin,
PEG-12, pentasodium triphosphate,
tetrapotassium pyrophosphate, flavor, sodium lauryl sulfate, cellulose
gum, sodium saccharin, charcoal
powder, xanthan gum, cocamidopropyl betaine, blue 1, red 40, yellow 5
QUES TIONS ?
1-800-468-6502
_Dist. by: _
_COLGATE-PALMOLIVE COMPANY_
_New York, NY 10022 U.S.A._
®
_New York, NY 10022 U.S.A._
PRINCIPAL DISPLAY PANEL - 130 G TUBE CARTON
NEW
Colgate
Anticavity Fluoride Toothpaste
ESSENTIALS™
WITH CHARCOAL
Daily toothpaste removes stains and impurities
for whiter teeth and fresher breath
NET WT 4.6 OZ (130g)
ENAMEL SAFE
FRESH MINT
®
COLGATE ESSENTIALS
sodium monofluorophosphate paste, dentifrice
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 59 54-78 6
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
1.0