APLICARE TOTAL JOINT PREP- povidone-iodine kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aplicare, Inc.

INN (International Name):

POVIDONE-IODINE

Composition:

POVIDONE-IODINE 9.8 g in 96.4 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic Stop use and ask a doctor if - redness, irritation, swelling or pain persists or increases - infection occurs

Authorization status:

OTC monograph not final

Summary of Product characteristics

APLICARE TOTAL JOINT PREP - POVIDONE-IODINE
APLICARE, INC.
_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._
----------
DRUG FACTS
ACTIVE INGREDIENT
Povidone-iodine USP
PURPOS E
Antiseptic
US E
antiseptic skin preparation
WARNINGS
Do not use
if allergic to iodine
in the eyes
For external use only
Avoid pooling beneath patient
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
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 percent titratable iodine
latex free
for hospital or professional use only
INACTIVE INGREDIENTS
citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water
1-800-760-3236 (Mon to Fri 8:30 AM-5:00 PM EST)
THREE POVIDONE-IODINE SWABSTICKS
Three 4-inch saturated swabsticks
STERILE unless opened or damaged.
3/4 FLUID OUNCE POVIDONE-IODINE SOLUTION
0.75 Fl. oz. (22.5 mL)
STERILE unless opened or damaged.
Total Joint Prep Kit
APLICARE TOTAL JOINT PREP
povidone-iodine kit
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:5238 0 -7310
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:5238 0 -7310 -0
50 in 1 CASE
1
1 in 1 KIT
QUANTITY OF PARTS
PART #
PACKAGE QUANTITY
TOTAL PRODUCT QUANTITY
PA RT 1
1 PACKET
6 .5 mL
PA RT 2
1 PACKET
30 mL
PART 1 OF 2
APLICARE POVIDONE-IODINE TRIPLES
povidone-iodine solution
PRODUCT INFORMATION
ITE M CODE (SOURCE )
NDC:5238 0 -310 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
9 .8 g in 9 6 .4 mL
INACTIVE INGREDIENTS
ING