APLICARE EXCEL AP- povidone-iodine and isopropyl alcohol solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4), ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)

Διαθέσιμο από:

Aplicare Products, LLC.

INN (Διεθνής Όνομα):

POVIDONE-IODINE

Σύνθεση:

IODINE 7.5 mg in 1 mL

Οδός χορήγησης:

TOPICAL

Τρόπος διάθεσης:

OTC DRUG

Θεραπευτικές ενδείξεις:

Antiseptic - for preparation of the skin prior to injection - helps reduce bacteria that can potentially cause skin infection D o not use on patients with known allergies to iodine or isopropyl alcohol Stop use and consult a physician if - redness, irritation or swelling occurs - condition persists for more than 72 hours - infection occurs

Καθεστώς αδειοδότησης:

OTC monograph not final

Αρχείο Π.Χ.Π.

APLICARE EXCEL AP- POVIDONE-IODINE AND ISOPROPYL ALCOHOL SOLUTION
APLICARE PRODUCTS, LLC.
_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._
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0039 APLICARE EXCEL AP
Isopropyl alcohol
Povidone-iodine
Antiseptic
US ES
for preparation of the skin prior to injection
helps reduce bacteria that can potentially cause skin infection
WARNINGS
FLAMMABLE
keep away from fire or flame
do not use with electrocautery devices
FOR EXTERNAL USE ONLY
D O NOT USE on patients with known allergies to iodine or isopropyl
alcohol
WHEN USING THIS PRODUCT keep out of the eyes
STOP USE AND CONSULT A PHYSICIAN IF
redness, irritation or swelling occurs
condition persists for more than 72 hours
infection occurs
KEEP OUT OF REACH OF CHILDREN. In case of accidental ingestion, seek
professional assistance or consult
a poison control center immediately.
DIRECTIONS
FOR PREPARATION FOR DRY SITES SUCH AS ABDOMEN, CHEST OR ARM
open package at tear notch
scrub with repeated back and forth motion for 10 SECONDS
allow prepped area to completely air dry
OTHER INFORMATION
store between 15-25°C (59-77°F)
avoid freezing and excessive heat
latex free
for hospital or professional use only
acrylates/steareth-20 methacrylate copolymer, aminomethyl propanol,
phosphoric acid, purified water
For questions, comments, or to report serious side effects:
800 760-3236
Monday-Friday
8:30 a.m. - 5:00 p.m. EST
ExCel AP
Povidone-Iodine
Antiseptic
NON-STERILE Solution
APLICARE EXCEL AP
povidone-iodine and isopropyl alcohol solution
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:5238 0 -0 0 39
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
PO VIDO NE-IO DINE (UNII: 8 5H0 HZU9 9 M) (IODINE - UNII:9 6 79 TC0
7X4)
IODINE
7.5 mg in 1 mL
ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2) (ISOPROPYL ALCOHOL -
UNII:ND2M416 30 2)
ISOPROP