COLGATE HYDRIS DRY MOUTH- 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:

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 HYDRIS DRY MOUTH- SODIUM FLUORIDE GEL, 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._
----------
COLGATE HYDRIS™ DRY MOUTH
_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, hydrogenated coconut oil,
sodium lauryl sulfate, flavor,
cellulose gum, sodium saccharin, tetrasodium pyrophosphate,
cocamidopropyl betaine, FD&C blue no.
1
QUES TIONS ?
1-800-468-6502
_Dist. by:_
®
_Dist. by:_
_COLGATE-PALMOLIVE COMPANY_
_New York, NY 10022 U.S.A._
PRINCIPAL DISPLAY PANEL - 119 G TUBE CARTON
_NEW_
_COLGATE_
_ANTICAVITY FLUORIDE TOOTHPASTE_
Soothes mouth dryness
Helps prevent cavities
Freshens breath
HYDRIS ™
DRY MOUTH
LOCKS IN A HYDRATED FEELING
4 HOURS OF LASTING COMFORT
NET WT 4.2 OZ (119 g)
1
COLGATE:
DENTIST RECOMMENDED
ORAL CARE BRAND
HYDRAMINT™
gel
®
#
COLGATE HYDRIS DRY MOUTH
sodium fluoride gel, dentifrice
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:350 0 0 -210
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
2.4 mg in 1 g
Colgate-Palmolive Company
INACTIVE INGREDIENTS
INGRED