APLICARE POVIDONE-IODINE SCRUB- 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 Products, LLC.

administration_route:

TOPICAL

prescription_type:

OTC DRUG

therapeutic_indication:

Antiseptic antiseptic skin preparation

authorization_status:

OTC monograph not final

SPC

APLICARE POVIDONE-IODINE SCRUB- POVIDONE-IODINE 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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0125 APLICARE POVIDONE-IODINE SCRUB
_DRUG FACTS_
ACTIVE INGREDIENT
Povidone-iodine USP 7.5%
PURPOS E
Antiseptic
US E
antiseptic skin preparation
WARNINGS
FOR EXTERNAL USE ONLY
DO NOT USE
if allergic to iodine
in the eyes
ASK A DOCTOR BEFORE USE IF INJURIES ARE
deep or puncture wounds
serious burns
STOP USE AND ASK A DOCTOR IF
redness, irritation, swelling or pain persists or increases
infection occurs
KEEP OUT OF REACH OF CHILDREN. In case of accidental ingestion, seek
professional assistance or consult
a poison control center immediately.
AVOID EXCESSIVE HEAT. Store at room temperature.
DIRECTIONS
apply locally as needed
OTHER INFORMATION
0.75% titratable iodine
not made with natural rubber latex
for hospital or professional use only
INACTIVE INGREDIENTS
ammonium nonoxynol-4 sulfate, 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 - 1 SWABSTICK PACKET
NDC 52380-0125-1
_A_PLICARE
Tear Here Hold Upright Tear Here
ONE
POVIDONE-IODINE
SCRUB SWABSTICK
ANTISEPTIC
NON-STERILE SOLUTION
One 4-inch saturated swabstick
REORDER NO. S-1112
APLICARE POVIDONE-IODINE SCRUB
povidone-iodine solution
Aplicare Products, LLC.
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:5238 0 -0 125
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
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
SO DIUM PHO SPHATE, DIBASIC (UNII: GR6 8 6 LBA74)
ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)
SO DIUM HYDRO XIDE (UNII: 55X0 4QC