DENTAL CLINIC 2080 CAVITY PROTECTION- sodium monofluorophosphate paste

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)

Verfügbar ab:

Aekyung Industrial Co., Ltd.

INN (Internationale Bezeichnung):

SODIUM MONOFLUOROPHOSPHATE

Zusammensetzung:

FLUORIDE ION 0.208 g in 160 g

Verabreichungsweg:

DENTAL

Verschreibungstyp:

OTC DRUG

Berechtigungsstatus:

OTC monograph final

Fachinformation

DENTAL CLINIC 2080 CAVITY PROTECTION- SODIUM MONOFLUOROPHOSPHATE PASTE
AEKYUNG INDUSTRIAL 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._
----------
If more than used for brushing is accidentally swallowed, get medical
help or contact a Poison Control
Center right away
Keep out of reach of children under 6 years of age
Sodium monofluorophosphate 0.75% (0.13% w/v Fluoride ion)
Sodium carboxymethylcellulose, Sodium lauryl sulfate, Sodium
saccharin, Sorbitol, Titanium dioxide,
Tocopheryl acetate, water
Purpose Anticavity
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
doctor.
Instruct children under 6 years of age in good brushing ad rinsing
habits (to minimize swallowing).
Supervise children as necessary until capable of using without
supervision.
Children under 2 years of age
Consult a dentist or doctor
Aids in the prevention of dental cavities
DENTAL CLINIC 2080 CAVITY PROTECTION
Aekyung Industrial Co., Ltd.
sodium monofluorophosphate paste
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 7225-0 0 0 1
ROUTE OF ADMINISTRATION
DENTAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRE NG TH
STRE NG TH
SO DIUM MO NO FLUO RO PHO SPHATE (UNII: C8 10 JCZ56 Q) (FLUORIDE ION -
UNII:Q8 0 VPU40 8 O)
FLUORIDE ION
0 .20 8 g
in 16 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
SO RBITO L (UNII: 50 6 T6 0 A25R)
9 2.8 g in 16 0 g
SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)
3.52 g in 16 0 g
CARBO XYMETHYLCELLULO SE SO DIUM (UNII: K6 79 OBS311)
0 .6 4 g in 16 0 g
TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)
0 .4 g in 16 0 g
SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)
0 .20 8 g in 16 0 g
ALPHA-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )
0 .4 g in 16 0 g
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END D