ORAL-B MINUTE-FOAM BANANA SPLITZ- acidulated phosphate fluoride aerosol

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Oral-B Laboratories

INN (Международно Name):

Sodium Fluoride

Композиция:

Fluoride ion 10 mg in 1 g

Начин на приложение:

DENTAL

Вид предписание :

PRESCRIPTION DRUG

Статус Оторизация:

unapproved drug other

Данни за продукта

ORAL-B MINUTE-FOAM BANANA SPLITZ - ACIDULATED PHOSPHATE FLUORIDE
AEROSOL
ORAL-B LABORATORIES
_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._
----------
PACKAGE.LABEL PRINCIPAL DISPLAY PANEL
MINUTE-FOAM
TOPICAL FLUORIDE FOAMING SOLUTION
(Acidulated Phosphate Fluoride Containing 1.23 % w/w Fluoride Ion)
FOR PROFESSIONAL USE ONLY
ACTIVE INGREDIENT:Acidulated Phosphate Fluoride (Sodium Fluoride and
Hydrofluoric Acid) 1.23 %
w/w fluoride ion.
DESCRIPTION:Oral-B Minute Foam is a flavored aqueous foaming solution
of acidulated phosphate
sodium fluoride with pH of 3.5 and a fluoride ion concentration of
1.23% w/w.
INACTIVE INGREDIENTS:Purified water, poloxamer 407, isobutane,
poloxamer 234, phosphoric acid,
sodium saccharin, flavor
CLINICAL PHARMACOLOGY: Acidulated Phosphate Fluoride inhibits caries
formation by
reducing enamel solubility and enhancing remineralization.
INDICATION AND USE:A topically-applied foaming solution to aid in the
prevention of dental
caries.
CONTRAINDICATIONS: Do not use in patients with hypersensitivity to
fluoride.
Do not use in patients with dysphagia.
WARNINGS: DO NOT SWALLOW
Accidental ingestion of the usual treatment dose (approx 12.4 mg of
fluoride) is not harmful. In the event
more than the treatment dose is swallowed, administer calcium (e.g.
milk) and get medical or contact a
Poison control Center right away. One bottle of Minute Foam contained
1.95 grams of fluoride ion
which could be lethal for children adults.
Keep out of the reach of infants and children under 12 years.
Pediatric patients under age 12 should be supervised during use of
this product.
Avoid spraying towards open flame.
Contents under pressure. Do not puncture or incinerate. Do not expose
to heat or store at temperatures
over 120 F (49 C).
PRECAUTIONS: FOR PROFESSIONAL USE ONLY
Laboratory studies have indicated that repeated use of Acidulated
Phosphate Fluoride products may dull
por