COLGATE TRIPLE ACTION ORIGINAL MINT FLUORIDE- sodium fluoride paste, dentifrice

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)

Available from:

Colgate-Palmolive Canada

Administration route:

DENTAL

Prescription type:

OTC DRUG

Therapeutic indications:

Anticavity helps protect against cavities

Authorization status:

OTC monograph final

Summary of Product characteristics

COLGATE TRIPLE ACTION ORIGINAL MINT FLUORIDE- SODIUM FLUORIDE PASTE,
DENTIFRICE
COLGATE-PALMOLIVE CANADA
_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._
----------
COLGATE
FLUORIDE TOOTHPASTE
_DRUG FACTS_
ACTIVE INGREDIENT
Sodium fluoride 0.24% (0.15% w/v fluoride ion)
PURPOS E
Anticavity
US E
helps protect against cavities
WARNINGS
KEEP OUT OF THE 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
sorbitol, water, hydrated silica, PEG-12, sodium lauryl sulfate,
flavor, cellulose gum, tetrasodium
pyrophosphate, cocamidopropyl betaine, sodium saccharin, titanium
dioxide, FD&C blue no. 1, FD&C
yellow no. 5
QUESTIONS OR COMMENTS?
CALL 1-800-468-6502
®
_Dist. by:_
_COLGATE-PALMOLIVE _
_COMPANY_
_New York, NY 10022_
_MADE IN CANADA _
_www.colgate.com_
PRINCIPAL DISPLAY PANEL - 181 G CARTON
_COLGATE_
_Fluoride Toothpaste_
_NET WT 6.4 OZ (181 g)_
_TRIPLE_
_ACTION_
_ORIGINAL MINT_
_CAVITY_
_PROTECTION_
_1_
_WHITER_
_TEETH_
_2_
_FRESH_
_BREATH_
_3_
_®_
Colgate-Palmolive Canada
COLGATE TRIPLE ACTION ORIGINAL MINT FLUORIDE
sodium fluoride paste, dentifrice
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:51442-536
ROUTE OF ADMINISTRATION
DENTAL
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)
So dium Fluo ride
2.4 mg in 1 g
PRODUCT CHARACTERISTICS
COLOR
BLUE, WHITE, GREEN
S C