APLICARE POVIDONE-IODINE- povidone-iodine solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Aplicare Products, LLC

Administracija rute:

TOPICAL

Tip recepta:

OTC DRUG

Terapijske indikacije:

Antiseptic - • antiseptic skin preparation - • single use when used for patient preoperative skin preparation

Status autorizacije:

OTC monograph not final

Svojstava lijeka

APLICARE POVIDONE-IODINE- POVIDONE-IODINE SOLUTION
APLICARE PRODUCTS, LLC
----------
2801APLICARE POVIDONE IODINE SOLUTION
_ACTIVE INGREDIENT_
Povidone-iodine 10%
(equivalent to 1% available iodine)
_PURPOSE_
Antiseptic
_USE_
• antiseptic skin preparation
• single use when used for patient preoperative skin preparation
_WARNINGS_
FOR EXTERNAL USE ONLY
AVOID "POOLING" BENEATH PATIENT. PROLONGED EXPOSURE TO WET SOLUTION
MAY
CAUSE SKIN IRRITATION.
DO NOT USE
• in the eyes
• on individuals allergic or sensitive to iodine
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_
• not made with natural rubber latex
• for hospital or professional use only
_INACTIVE INGREDIENTS_
citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water
MANUFACTURING INFORMATION
Manufactured by:
Aplicare Products, LLC
550 Research Way, Meriden, CT 06450 USA
Made in USA
REF: APL82342K
RL17HND
PACKAGE LABEL
APLICARE POVIDONE-IODINE
povidone-iodine solution
Aplicare Products, LLC
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:52380-2801
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
IODINE
10 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
NONOXYNOL-9 (UNII: 48Q180SH9T)
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:52380-
2801-8
59 mL in 1 BOTTLE; Type 0: Not a Combination
Product
01/01/1998
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION