CURITY POVIDONE-IODINE ONE-STEP PREP- povidone-iodine gel

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

CURITY POVIDONE-IODINE ONE-STEP PREP- POVIDONE-IODINE GEL
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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4193 CURITY POVIDONE-IODINE ONE-STEP PREP
_ACTIVE INGREDIENT_
Povidone-iodine USP 10%
_PURPOSE_
Antiseptic
_USE_
antiseptic skin preparation
_WARNINGS_
FOR EXTERNAL USE ONLY.
AVOID "POOLING BENEATH PATIENT. PROLONGED EXPOSURE TO WET SOLUTION MAY
CAUSE SKIN IRRITATION.
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
• infection occurs
• redness, irritation, swelling or pain persists or increases
KEEP OUT OF REACH OF CHILDREN.
In case of accidental ingestion, seek professional assistance or
consult a Poison
Control Center immediately.
_DIRECTIONS_
• apply locally as needed
_OTHER INFORMATION_
• 1% titratable iodine
• for hospital or professional use only
• avoid freezing and excessive heat (above 104°F)
• not made with natural rubber latex
_INACTIVE INGREDIENTS_
disodium phosphate, glycerin, hydroxyethylcellulose, nonoxynol-10,
simethicone, water
MANUFACTURING INFORMATION
Manufactured for:
Covidien LLC
15 Hampshire Street, Mansfield MA 02048 USA
HP105792
REF: APL41461
PACKAGE LABEL
CURITY POVIDONE-IODINE ONE-STEP PREP
povidone-iodine gel
Aplicare Products, LLC
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:52380-4193
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
IODINE
9.7 g in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL HYDROXYETHYLCELLULOSE (550000 MW) (UNII: 2MIM45ZIL3)
NONOXYNOL-10 (UNII: K7O76887AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0