COLGATE LUMINOUS CRYSTAL FLUORIDE- sodium fluoride gel, dentifrice

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)

Available from:

Mission Hills S.A. de C.V.

INN (International Name):

SODIUM FLUORIDE

Composition:

FLUORIDE ION 1.1 mg in 1 g

Administration route:

DENTAL

Prescription type:

OTC DRUG

Therapeutic indications:

Anticavity helps protect against cavities

Authorization status:

OTC monograph final

Summary of Product characteristics

COLGATE LUMINOUS CRYSTAL FLUORIDE- SODIUM FLUORIDE GEL, 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._
----------
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, mica,
titanium dioxide, FD&C blue no.1
QUESTIONS OR COMMENTS?
Call toll-free 1-800-468-6502
_Dist. by:_
®
_COLGATE-PALMOLIVE COMPANY_
_New York, NY 10022_
_Made in Mexico_
_www.colgateluminous.com_
PRINCIPAL DISPLAY PANEL - 113 G CARTON
_COLGATE_
_ _
_FLUORIDE TOOTHPASTE_
ADA
ACCEPTED
AMERICAN
DENTAL
ASSOCIATION ®
_NET WT 4.0 OZ (113 G)_
_LUMINOUS_
_ENAMEL STRENGTHENING_
_CRYSTAL CLEAN MINT™_
33%
FREE
3.0OZ + 1.0OZ
_®_
COLGATE LUMINOUS CRYSTAL FLUORIDE
sodium fluoride gel, dentifrice
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 59 54-0 22
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)
FLUORIDE ION
1.1 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
SO RBITO L (UNII: 50 6 T6 0