COLGATE MINIONS MILD BUBBLE FRUIT 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:

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 MINIONS MILD BUBBLE FRUIT FLUORIDE- SODIUM FLUORIDE 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._
----------
COLGATE MINIONS MILD BUBBLE FRUIT 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 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, cellulose gum, sodium lauryl
sulfate, flavor, sodium
saccharin, mica, titanium dioxide, D&C yellow no. 10, FD&C blue no. 1
QUES TIONS ?
1-800-468-6502
_Dist. by:_
_COLGATE-PALMOLIVE COMPANY_
_New York, NY 10022_
®
™
®
PRINCIPAL DISPLAY PANEL - 130 G TUBE LABEL
_COLGATE_
_FLUORIDE TOOTHPASTE_
_CLINICALLY PROVEN_
_CAVITY & ENAMEL PROTECTION_
ILLUMINATION
ENTERTAINMENT
MINIONS
ADA
ACCEPTED
AMERICAN
DENTAL
ASSOCIATION ®
_TOOTHPASTE_
_NET WT _
_4.6 OZ _
_(130 G)_
MILD BUBBLE FRUIT
®
™
®
COLGATE MINIONS MILD BUBBLE FRUIT FLUORIDE
sodium fluoride paste, dentifrice
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 59 54-779
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 A25R)