POVIDONE-IODINE TOPICAL ANTISEPTIC- povidone-iodine solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Medline Industries, LP

INN (International Name):

POVIDONE-IODINE

Composition:

IODINE 10 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic - healthcare antiseptic for preparation of the skin prior to surgery - first aid antiseptic to help prevent infection in minor cuts, scrapes and burns

Authorization status:

OTC monograph not final

Summary of Product characteristics

POVIDONE-IODINE TOPICAL ANTISEPTIC- POVIDONE-IODINE SOLUTION
MEDLINE INDUSTRIES, LP
----------
939 PVP PREP SOLUTION
_ACTIVE INGREDIENT_
Povidone Iodine 10%
(equivalent to 1% available iodine)
_PURPOSE_
Antiseptic
_USES_
healthcare antiseptic for preparation of the skin prior to surgery
first aid antiseptic to help prevent infection in minor cuts, scrapes
and burns
_WARNINGS_
FOR EXTERNAL USE ONLY.
DO NOT USE
in the eyes
longer than 1 week unless directed by a doctor
on individuals who are allergic or sensitive to iodine
or apply over large areas of the body
STOP USE AND ASK A DOCTOR IF
irritation and redness develop
condition persists for more than 72 hours
in case of deep or puncture wounds, animal bites or serious burns
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
_DIRECTIONS_
Clean the affected area.
FOR PREPARATION OF THE SKIN PRIOR TO SURGERY: apply product to the
operative site
prior to surgery
FOR FIRST AID ANTISEPTIC: apply a small amount of this product on the
area 1 to 3
times daily. May be covered with a sterile bandage. If bandaged, let
dry first.
_OTHER INFORMATION_
protect from freezing, avoid excessive heat
_INACTIVE INGREDIENTS_
citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water
MANUFACTURING INFORMATION
Manufactured by:
Medline Industries, LP
Three Lakes Drive, Northifeld, IL 60093 USA
Made in USA
www.medline.com
1-800-MEDLINE (633-5463)
REF: MDS093941
V1 RB22DYN
REF: 55114
V2 RB24HND
PACKAGING LABELS
POVIDONE-IODINE TOPICAL ANTISEPTIC
povidone-iodine solution
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:53329-939
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
IODINE
10 mg in 1 mL
Medline Industries, LP
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)
NONOXYNOL-9 (UNII: 48Q1