CERTUS PVP-1 PREP SWABSTICK- povidone-iodine swab

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Certus Medical, Inc.

INN (International Name):

POVIDONE-IODINE

Composition:

POVIDONE-IODINE 0.1 mL in 1 mL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic health-care antiseptic for preparation of the skin prior to surgery in the eyes over large areas of the body on individuals who are allergic or sensitive  to iodine and consult a doctor if redness, irritation, swelling, or pain persists or increases

Authorization status:

OTC monograph not final

Summary of Product characteristics

CERTUS PVP-1 PREP SWABSTICK - POVIDONE-IODINE SWAB
CERTUS MEDICAL, 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._
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CERTUS PVP-1 PREP SWABSTICK 210012 DRUG FACTS AND LABEL
DRUG FACTS BOX OTC ACTIVE INGREDIENT SECTION
Povidone Iodine USP 10%
equivalent to 1% titratable iodine
DRUG FACTS BOX OTC PURPOSE SECTION
Antiseptic
DRUG FACTS BOX OTC INDICATIONS & USAGE SECTION
health-care antiseptic for preparation of the skin prior to surgery
DRUG FACTS BOX OTC WARNINGS SECTION
for external use only
DRUG FACTS BOX OTC DO NOT USE SECTION
in the eyes
over large areas of the body
on individuals who are allergic or sensitive to iodine
DRUG FACTS BOX OTC ASK DOCTOR SECTION
in case of deep or puncture wounds, animal bites, or serious burns
DRUG FACTS BOX OTC STOP USE SECTION
and consult a doctor if redness, irritation, swelling, or pain
persists or increases
DRUG FACTS BOX OTC KEEP OUT OF REACH OF CHILDREN SECTION
in case of accidental ingestion, seek professional assistance or
consult a Poison Control Center
immediately
DRUG FACTS BOX OTC DOSAGE & ADMINISTRATION SECTION
for preparation of the skin prior to surgery
remove swab by stick
clean the area
apply product to the operative site prior to surgery
DRUG FACTS BOX OTC GENERAL PRECAUTIONS SECTION
store at room temperature 15 - 30 C (59 - 86 F)
DRUG FACTS BOX OTC INACTIVE INGREDIENT SECTION
disodium phosphate, glycerin, hydroxyethylcellulose, nonoxynol-10,
dimethicone, water
CERTUS PVP-1 PREP SWABSTICK 210012 POUCH
210012.jpg Certus PVP-1 Prep Swabstick pouch
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CERTUS PVP-1 PREP SWABSTICK
povidone-iodine swab
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:759 9 0 -40 19
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) (POVIDONE-IODINE - UNII:8
5H0 HZU9 9 M)
POVIDONE-IODINE