Leader Povidone-Iodine 10% Topical Solution: Package Insert and Label Information

LEADER POVIDONE-IODINE 10% TOPICAL SOLUTION- povidone-iodine liquid
Cardinal Health

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.

Warnings

For external use only

Do Not Use

  • if allergic to iodine
  • in the eyes

Stop use and ask a doctor if

  • irritation and redness develop
  • condition persists for more than 72 hours

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Inactive Ingredients

Citric Acid Anhydrous, Disodium Phosphate Anhydrous, Glycerin, Polysorbate 80, Puried Water, Sodium Citrate USP

Active Ingredient

Povidone-iodine 10%

Purpose

Healthcare Antiseptic

Use

For preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection

Directions

Clean the area. Apply product to the operative site prior to surgery.

Other

Store at controlled room temperature 15º-30ºC (59º-86ºF).

Questions?

1-888-396-2739

Labeling

CR-5667761 IN Master
(click image for full-size original)

LEADER POVIDONE-IODINE 10% TOPICAL SOLUTION
povidone iodine prep solution 10% liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0060
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POVIDONE-IODINE (IODINE) IODINE 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
WATER
POLYSORBATE 80
SODIUM CITRATE
ANHYDROUS CITRIC ACID
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70000-0060-1 237 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 09/25/2020
Labeler — Cardinal Health (063997360)
Registrant — Dynarex Corporation (008124539)

Revised: 11/2022 Cardinal Health

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