Country: United States
Language: English
Source: NLM (National Library of Medicine)
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)
ECOWORLDPHARM CO.,LTD
DENTAL
OTC DRUG
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
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 sodium fluoride liquid PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:61284-0013 ROUTE OF ADMINISTRATION DENTAL ECOWORLDPHARM CO.,LTD 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- 0013-2 250 in 1 PACKAGE 10/05/2023 1 NDC:61284- 0013-1 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(61284-0013) Rev Read the complete document