LEADER POVIDONE IODINE- povidone iodine 10% liquid liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cardinal Health, 110 dba Leader

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

First aid antiseptic to help prevent infection in minor cuts, scrapes and burns First Aid Antiseptic

Authorization status:

OTC monograph not final

Summary of Product characteristics

LEADER POVIDONE IODINE- POVIDONE IODINE 10% LIQUID LIQUID
CARDINAL HEALTH, 110 DBA LEADER
_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._
----------
LEADER POVIDONE IODINE
Povidone-Iodine 10%
First aid antiseptic to help prevent infection in minor cuts, scrapes
and burns
Clean the affected area
apply a small amount on the area 1 to 3 times dailly
may be covered with sterile bandage
if bandaged let dry first
WARNINGS FOR EXTERNAL USE ONLY.
ASK A DOCTOR BEFORE USE IF YOU HAVE
deep or puncture wounds
animal bites
serious burns
KEEP OUT OF REACH OF CHILDREN. If swallowed, seek medical help or
contact a Poison
Control Center (1-800-222-1222) immediately.
Citric Acid
Disodium Phosphate
Glycerin
Nonoxynol-9
Sodium Hydroxide
Purified Water
First Aid Antiseptic
LEADER POVIDONE IODINE
povidone iodine 10% liquid liquid
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:70000-0402
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
IODINE
100 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
GLYCERIN (UNII: PDC6A3C0OX)
NONOXYNOL-9 (UNII: 48Q180SH9T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B)
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
Cardinal Health, 110 dba Leader
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70000-
0402-1
237 mL in 1 CONTAINER; Type 0: Not a
Combination Product
02/26/2019
01/31/2023
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC monograph not
final
part333A
02/26/2019
01/31/2023
LABELER -
Cardinal Health, 110 dba Leader (063997360)
Revised: 12/2022