POVIDONE-IODINE solution

POVIDONE-IODINE by

Drug Labeling and Warnings

POVIDONE-IODINE by is a Otc medication manufactured, distributed, or labeled by HART Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Povidone Iodine 10% (available iodine 1%)

Purpose

Topical antiseptic

Uses

First aid topical antiseptic to help prevent infection in

• minor cuts
• scrapes
• abrasions

Warnings

For external use only.

• do not get in eyes

ASK DOCTOR

Ask a dcotor before use if you have

• deep or puncture wounds
• serious burns

STOP USE

Stop use and ask a doctor if

• redness, irritation, swelling or pain persists or increases
• infection occurs

DO NOT USE

Do not use

• on animal bits
• in or near the eyes or over large portions of the body

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, get medical help immediately or contact a Poison Control Center right away. 1-800-222-1222

Directions

Adults and children 12 years of age and older:

• reverse cardboard sleeve
• crush at dot between thumb and forefinger to release fluid
• gently wipes injured area to clean and disinfect
• dispose of swab peoperly
• do not reuse swab

Children under 12 years of age: ask a doctor

Other information

 Store at room temperaturem 59° - 86°F (15° - 30°C) away from light. Keep from freezing or excessive heat.

Inactive ingredients

citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water.

Packaging

INGREDIENTS AND APPEARANCE

POVIDONE-IODINE 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50332-0056
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

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
NONOXYNOL-9 (UNII: 48Q180SH9T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50332-0056-1	10 in 1 BOX, UNIT-DOSE	01/01/1980
1		0.6 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	01/01/1980

Labeler - HART Health (069560969)