APLICARE POVIDONE-IODINE PAINT- povidone-iodine solution

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)

MAH:

Aplicare, Inc.

administration_route:

TOPICAL

prescription_type:

OTC DRUG

therapeutic_indication:

Antiseptic antiseptic skin preparation

authorization_status:

OTC monograph not final

SPC

APLICARE POVIDONE-IODINE PAINT- POVIDONE-IODINE SOLUTION
APLICARE, INC.
_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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APLICARE POVIDONE-IODINE PAINT
_DRUG FACTS_
ACTIVE INGREDIENT
Povidone-iodine USP 10%
PURPOS E
Antiseptic
US E
antiseptic skin preparation
WARNINGS
DO NOT USE
if allergic to iodine
in the eyes
ASK A DOCTOR BEFORE USE IF INJURIES ARE
deep wounds
puncture wounds
serious burns
STOP USE AND ASK A DOCTOR IF
redness, irritation, swelling or pain persists or increases
infection occurs
FOR EXTERNAL USE ONLY
KEEP OUT OF REACH OF CHILDREN. In case of accidental ingestion, seek
professional assistance or consult
a poison control center immediately.
AVOID POOLING BENEATH THE PATIENT. Prolonged exposure to wet solution
may cause skin irritation.
AVOID EXCESSIVE HEAT. Store at room temperature.
DIRECTIONS
use sponge sticks to prep desired area
OTHER INFORMATION
1% titratable iodine
for single use only
not made with natural rubber latex
for hospital or professional use only
INACTIVE INGREDIENTS
citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water
For questions, comments, or to report serious side effects:
800-760-3236
Monday-Friday 8:30 a.m.-5:00 p.m. EST
PRINCIPAL DISPLAY PANEL - 2 SPONGE STICKS PACKET
NDC 52380-4011-2
_A_PLICARE
Tear Here Hold Upright Tear Here
TWO POVIDONE-IODINE PAINT
SPONGE STICKS
ANTISEPTIC
NON-STERILE SOLUTION
Two 8-inch Sponge Sticks Saturated with
Povidone-Iodine USP, 1% Available Iodine
REORDER NO. F-2011
Aplicare, Inc.
APLICARE POVIDONE-IODINE PAINT
povidone-iodine solution
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:5238 0 -40 11
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
10 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
ST