ACL4SP SINGLE SHOT EPIDURAL- kit

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

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Produktens egenskaper Produktens egenskaper (SPC)
01-04-2015

Aktiva substanser:

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

Tillgänglig från:

Clint Pharmaceuticals, Inc.

Terapeutiska indikationer:

Antiseptic Antiseptic skin preparation Stop use and ask a doctor if -redness, irritation, swelling or pain persists or increases -infection occurs Avoid pooling beneath patient Avoid excessive heat. Store at room temperature. Apply locally as needed.

Bemyndigande status:

Premarket Notification

Produktens egenskaper

                                ACL4SP SINGLE SHOT EPIDURAL - REGIONAL ANESTHESIA KIT
CLINT PHARMACEUTICALS, INC.
----------
DRUG FACTS
Povidone-iodine
Antiseptic
Antiseptic skin preparation
Do not use
-if allergic to iodine
-in the eyes
For external use only
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
Avoid pooling beneath patient
Avoid excessive heat. Store at room temperature.
Keep out of reach of children
In case of accidental ingestion, seek professional assistance or
consult a poison control center
immediately.
Apply locally as needed.
1% titratable iodine latex free for hospital or professional use only
citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water
1 800 760-3236 (Mon to Fri 8:30 AM-5:00 PM EST)
Package Label Display Panel
Package Label Display Panel
ACL4SP SINGLE SHOT EPIDURAL
regional anesthesia kit kit
PRODUCT INFORMATION
PRODUCT T YPE
MEDICAL DEVICE
ITE M CODE (SOURCE )
NHRIC:55553-445
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NHRIC:55553-445-0 2
30 in 1 CASE
1
1 in 1 PACKAGE, COMBINATION
QUANTITY OF PARTS
PART #
PACKAGE QUANTITY
TOTAL PRODUCT QUANTITY
PA RT 1
1 PACKET
22.5 mL
PART 1 OF 1
APLICARE POVIDONE-IODINE
povidone-iodine solution
PRODUCT INFORMATION
ITE M CODE (SOURCE )
NDC:5238 0 -0 0 0 1
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
STRE NG TH
CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)
SO DIUM PHO SPHATE, DIBASIC (UNII: GR6 8 6 LBA74)
SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)
NO NO XYNO L-9 (UNII: 48 Q18 0 SH9 T)
WATER (UNII: 0 59 QF0 KO0 R)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:5238 0 -0 0 0 1-3
22.5 mL in 1 PACKET
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUM
                                
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