ATOMY TOOTHPASTE - sodium fluoride paste, dentifrice

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O), SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)

Доступна с:

ATOMY CO LTD

Администрация маршрут:

DENTAL

Тип рецепта:

OTC DRUG

Статус Авторизация:

OTC monograph final

Характеристики продукта

ATOMY TOOTHPASTE - SODIUM FLUORIDE PASTE, DENTIFRICE
ATOMY CO LTD
_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._
----------
ATOMY TOOTHPASTE
DRUG FACTS
ACTIVE INGREDIENTS
Sodium Monofluorophosphate 0.16%
Sodium Fluoride 0.1%
USES
aid in the prevention of dental cavities
DIRECTIONS
Adults and children 2 years of age and older
;Brush teeth throughly preferably after each meal or at least twice a
day or as directed by a dentist or
doctor.
Children under 6 years
;To minimize swallowing, use a pea-sized amount and supervise brushing
until good habits are
established.
Children under 2 years
;Consult a dentist or doctor.
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.
ATOMY TOOTHPASTE
200g/7.05 fl.oz
ATOMY TOOTHPASTE
sodium fluoride paste, dentifrice
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:52257-10 0 3
ROUTE OF ADMINISTRATION
DENTAL
ATOMY CO LTD
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)
SODIUM FLUORIDE
0 .2 g
in 20 0 g
SO DIUM MO NO FLUO RO PHO SPHATE (UNII: C8 10 JCZ56 Q) (FLUORIDE ION -
UNII:Q8 0 VPU40 8 O)
SODIUM
MONOFLUOROPHOSPHATE
0 .32 g
in 20 0 g
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:52257-10 0 3-2
1 in 1 BOX
1
NDC:52257-10 0 3-1
20 0 g in 1 TUBE
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
OTC mo no graph final
pa rt355
0 5/25/20 10
LABELER -
AT OMY CO LT D (631154601)
Revised: 5/2010