ACL5SPS SINGLE SHOT EPIDURAL- kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Clint Pharmaceuticals, Inc.

Therapeutic indications:

APLICARE POVIDONE-IODINE SOLUTION (povidone-iodine solution) solution [Aplicare, Inc.] 3/4 Ounce Povidone Iodine Packet

Authorization status:

Premarket Notification

Summary of Product characteristics

ACL5SPS SINGLE SHOT EPIDURAL - REGIONAL ANESTHESIA KIT
CLINT PHARMACEUTICALS, INC.
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APLICARE POVIDONE-IODINE SOLUTION (povidone-iodine solution) solution
[Aplicare, Inc.]
3/4 Ounce Povidone Iodine Packet
Povidone-iodine 10%
Antiseptic
Warnings
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
Keep out of reach of children. In case of accidental ingestion, seek
professionalassistance or
consult a poison control center immediately.
Package Label Display Panel
Package Label Display Panel
ACL5SPS SINGLE SHOT EPIDURAL
regional anesthesia kit kit
PRODUCT INFORMATION
PRODUCT T YPE
MEDICAL DEVICE
ITE M CODE (SOURCE )
NHRIC:55553-46 4
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NHRIC:55553-46 4-0 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)
POVIDONE-IODINE
0 .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 NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
OTC mo no graph no t final
pa rt333A
0 3/0 1/19 8 4
MARKETING INFORMATION
MARKE TING CATE