MAJOR POVIDONE IODINE- povidone-iodine ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Major Pharmaceuticals

INN (International Name):

POVIDONE-IODINE

Composition:

IODINE 100 mg in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic-germicidal for the treatment of: - minor wounds - infections - kills bacteria promptly

Authorization status:

OTC monograph final

Summary of Product characteristics

MAJOR POVIDONE IODINE- POVIDONE-IODINE OINTMENT
MAJOR PHARMACEUTICALS
_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 USP10% w/w (available iodine 1%)
PURPOS E
Antiseptic-germicidal
US ES
for the treatment of:
minor wounds
infections
kills bacteria promptly
WARNINGS
FOR EXTERNAL USE ONLY.
DO NOT USE
over large areas of the body
if you are allergic to any of the ingredients
longer than 1 week unless directed by a doctor
WHEN USING THIS PRODUCT
AVOID CONTACT WITH EYES.
ASK A DOCTOR BEFORE USE IF YOU HAVE
deep or puncture wounds
animal bites
serious burns
STOP USE AND ASK A DOCTOR IF
redness, irritation or swelling occurs or pain persists
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
In case of accidental ingestion, seek professional assistance or
contact a Poison Control Center
immediately.
DIRECTIONS
apply directly to affected area
may be bandaged
OTHER INFORMATION
Store at controlled room temperature 15°-30°C (59°-86°F).
Close cap tightly after use.
For control no. and expiration date, see carton and/or crimp of tube.
Will not stain natural fabrics.
Protect from freezing.
INACTIVE INGREDIENTS
glycerin, PEG-6, PEG-32, propylene glycol
QUES TIONS ?
Adverse Drug Event call [phone]
Dist. By MAJOR PHARMACEUTICALS
31778 Enterprise Drive, Livonia, Ml 48150 USA
Re-Oder No. 100433 M-101
PRINCIPAL DISPLAY PANEL – 1 OZ. TUBE
MAJOR
NDC 0904-1102-31
POVIDINE™
FIRST AID OINTMENT
NET WT. 1 OZ (28.35 g) *Compare to
POVIDINE – IODINE 10% Active Ingredient of
AVAILABLE IODINE 1% Betadine® Ointment
®
PRINCIPAL DISPLAY PANEL – 1 OZ. CARTON
MAJOR
NDC 0904-1102-31
POVIDINE™ *Compare to
FIRST AID OINTMENT Active Ingredient of
NET WT. 1OZ (28.35 g) POVIDINE - IODINE 10% Betadine® Ointment
®
MAJOR POVIDONE IODINE
povidone-iodine ointment
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M