TRUWELL DENTIWASH- sodium fluoride liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

ECOWORLDPHARM CO.,LTD

Administration route:

DENTAL

Prescription type:

OTC DRUG

Therapeutic indications:

aids in the prevention of dental cavities Adults and children 6 years of age and older: use twoce a day after brishing your teeth with a toothpaste vigorously swish contents of one (1) 11mL packet between your teeth for 1 minute and then spit out do not swallow the rinse do not eat or drink for 30 minutes after rinsing instruct children under 12 years of age in good rinsing habits (to minimize swallowing) supervise children as necessary until capable of using without supervision Children uder 6 years of age: consult a dentist or doctor

Summary of Product characteristics

TRUWELL DENTIWASH- SODIUM FLUORIDE LIQUID
ECOWORLDPHARM CO.,LTD
----------
DRUG FACTS
sodium fluoride
purified water, glycerin, xylitol, green tea extract, acetic acid,
strawberry flavoring,
sodium acetate, grapefruit seed extract, sodium benzoate, L-menthol,
sodium
saccharin, chitosan
aids in the prevention of dental cavities
KEEP OUT OF REACH OF THE CHILDREN
Adults and children 6 years of age and older:
use twoce a day after brishing your teeth with a toothpaste
vigorously swish contents of one (1) 11mL packet between your teeth
for 1 minute and
then spit out
do not swallow the rinse
do not eat or drink for 30 minutes after rinsing
instruct children under 12 years of age in good rinsing habits (to
minimize swallowing)
supervise children as necessary until capable of using without
supervision
Children uder 6 years of age: consult a dentist or doctor
if more than used for rinsing is accidentally swallowed, get medical
help or contact a
Poison Control Center right away
for dental use only
TRUWELL DENTIWASH
ECOWORLDPHARM CO.,LTD
sodium fluoride liquid
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:61284-0012
ROUTE OF ADMINISTRATION
DENTAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION -
UNII:Q80VPU408O)
SODIUM FLUORIDE
0.05 g in 100 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
XYLITOL (UNII: VCQ006KQ1E)
MALIC ACID (UNII: 817L1N4CKP)
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:61284-
0012-2
30 in 1 PACKAGE
10/05/2023
1
NDC:61284-
0012-1
11 mL in 1 PACKAGE; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC Monograph Drug
M021
10/05/2023
LABELER -
ECOWORLDPHARM CO.,LTD (688735061)
REGISTRANT -
ECOWORLDPHARM CO.,LTD (688735061)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
ECOWORLDPHARM CO.,LTD
688735061
manufacture(61284-0012)
Revi