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
TRIPLE
ACTION
ORIGINAL MINT
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 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?
1-800-468-6502
_Dist. by:_
_COLGATE-PALMOLIVE COMPANY_
_New York, NY 10022_
_Made in Canada_
_WWW.COLGATE.COM_
®
PRINCIPAL DISPLAY PANEL - 130 G TUBE
_COLGATE_
_Fluoride Toothpaste_
_NET WT 4.6 OZ (130 g)_
_TRIPLE_
_ACTION_
_ORIGINAL MINT_
_CAVITY PROTECTION_
_1_
_WHITER TEETH_
_2_
_FRESH BREATH_
_3_
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) (Fluo ride Io n - UNII:Q8 0
VPU40 8 O)
So dium Fluo ride
2.4 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
SO RBITO L (UNII: 50 6 T6 0 A25R)
WA TER (UNII: 0