COLGATE OPTIC WHITE STAIN FIGHTER WITH BAKING SODA- 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 Company

Administration route:

DENTAL

Prescription type:

OTC DRUG

Therapeutic indications:

Anticavity helps protect against cavities

Authorization status:

OTC monograph final

Summary of Product characteristics

COLGATE OPTIC WHITE STAIN FIGHTER WITH BAKING SODA- SODIUM FLUORIDE
PASTE, DENTIFRICE
COLGATE-PALMOLIVE COMPANY
_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 OPTIC WHITE STAIN FIGHTER
WITH BAKING SODA
_DRUG FACTS_
ACTIVE INGREDIENT
Sodium Fluoride 0.24% (0.15% w/v fluoride ion)
PURPOSE
Anticavity
USE
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
ask a dentist or physician
INACTIVE INGREDIENTS
Water, Sorbitol, Hydrated Silica, PEG-12, Sodium Lauryl Sulfate,
Flavor, Cellulose Gum, Potassium Hydroxide,
Tetrasodium Pyrophosphate, Phosphoric Acid, Cocamidopropyl Betaine,
Sodium Saccharin, Benzyl Alcohol,
Sodium Bicarbonate.
QUESTIONS?
1-800-468-6502
_Dist. by:_
_COLGATE-PALMOLIVE COMPANY_
_New York, NY 10022 U.S.A._
PRINCIPAL DISPLAY PANEL - 170 G TUBE CARTON
Colgate
Anticavity Fluoride Toothpaste
OPTIC
WHITE
®
®
®
®
®
®
STAIN FIGHTER
WITH BAKING SODA
REMOVES 5X MORE SURFACE STAINS*
WITH MICRO-POLISHING ACTION
ENAMEL SAFE
NET WT 6.0 OZ (170 g)
CLEAN MINT PASTE
COLGATE OPTIC WHITE STAIN FIGHTER WITH BAKING SODA
sodium fluoride paste, dentifrice
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:35000-264
ROUTE OF ADMINISTRATION
DENTAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)
FLUORIDE ION
1.1 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WA