APLICARE POVIDONE-IODINE SCRUB- povidone-iodine solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Aplicare Products, LLC

Podání:

TOPICAL

Druh předpisu:

OTC DRUG

Terapeutické indikace:

Antiseptic - • antiseptic skin preparation - • single use when used for patient preoperative skin preparation and/or preinjection indications

Stav Autorizace:

OTC monograph not final

Charakteristika produktu

APLICARE POVIDONE-IODINE SCRUB- POVIDONE-IODINE SOLUTION
APLICARE PRODUCTS, LLC
----------
2802 APLICARE POVIDONE-IODINE SCRUB
_ACTIVE INGREDIENT_
Povidone Iodine 7.5%
_PURPOSE_
Antiseptic
_USE_
• antiseptic skin preparation
• single use when used for patient preoperative skin preparation
and/or preinjection
indications
_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, or 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_
ammonium nonoxynol-4 sulfate, citric acid, disodium phosphate,
nonoxynol-9, sodium
hydroxide, water
MANUFACTURING INFORMATION
Manufactured by:
Aplicare Products, LLC
550 Reasearch Pkwy, Meriden, CT 06450 USA
Made in USA
REF: APL82362K
RL17HND
PACKAGE LABEL
Aplicare Products, LLC
APLICARE POVIDONE-IODINE SCRUB
povidone-iodine solution
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:52380-2802
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
IODINE
7.5 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
NONOXYNOL-9 (UNII: 48Q180SH9T)
AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:52380-
2802-8
59 mL in 1 BOTTLE; Type 0: N