NAFRINSE PACKETSKIT GRAPE- sodium fluoride powder

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)

Available from:

Young Dental Manufacturing I, LLC

INN (International Name):

Sodium Fluoride

Composition:

Fluoride Ion 1 g in 1 g

Administration route:

DENTAL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

unapproved drug other

Summary of Product characteristics

NAFRINSE PACKETSKIT GRAPE- SODIUM FLUORIDE POWDER
YOUNG DENTAL MANUFACTURING I, LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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CONVINIENCE KIT -20 PACK OF NAFRINSE PACKETS, A POLYETHYLENE JUG,
DISPENSER PUMP, PLASTIC CUPS,
PAPER NAPKINS, AND TRASH BAG WITH TIES
INACTIVES
Saccharin Sodium, Potassium Sorbate, Citric Acid, Flavoring
Dye
WARNING:
This Packet contains sodium fluoride powder, contents poisonous if
swallowed. keep away from
children. Store in a dry place at controlled room temperature. For
professional use only.
DO NOT SWALLOW
MISSUSE If child swallows dispensed amount of mouth rinse in a cup:
1. Do not panic -this amount should not hurt the child
2. In rare cases the child may feel slightly nauseous.
The child may have a serving of milk or ice cream to relieve the
nausea. EMERGENCY TREATMENT
If a child swallows more than one dispensed amount in a cup or powder
contents of the fluoride mouth
rinse packet call the Poison Control Center at 800-222-1222
DIRECTIONS
Mix contents with stated amount of tap water until dissolved (read
directions on jug label) Makes an 0.2
% solution of sodium fluoride mouthrinse aftert dilution. Swish 10 ml
(2 teaspoons) around vigorously
in the mouth for one minute and then spit out. To be used once a week.
NAFRINSE PACKETSKIT GRAPE
sodium fluoride powder
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:0 273-8 0 0 9
ROUTE OF ADMINISTRATION
DENTAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
SO DIUM FLUO RIDE (UNII: 8 ZYQ1474W7) (Fluo ride Io n - UNII:Q8 0
VPU40 8 O)
Fluo ride Io n
1 g in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)
PO TA SSIUM SO RBA TE (UNII: 1VPU26 JZZ4)
ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)
PRODUCT CHARACTERISTICS
COLOR
S CORE
S HAP E
S IZ E
FLAVOR
GRAPE (grape)
IMPRINT CODE
CONTAINS
PACKAG