Scrubidine Label

Drug Labeling and Warnings

Drug Details [pdf]

SCRUBIDINE  POVIDONE IODINE SURGICAL SCRUB- povidone iodine liquid 
Medical Chemical Corporation

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.

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Scrubidine Label

Povidone Iodine Surgical Scrub

(0.75% available Iodine)

Warning: Contains Iodine.  In case of accidental ingestion call a physician or poison control center and treat for Iodine poisoning.  Keep out of reach of children.

Warning: Contains Iodine.  In case of accidental ingestion call a physician or poison control center and treat for Iodine poisoning.  Keep out of reach of children.

Directions for use: Wet hands with water and pour about 5 ml on the palm of hand.  Scrub thoroughly over all areas in both hands for at least 5 min., using a brush as needed.  Rinse thoroughly under running water.  Repeat as needed.

Directions for use: Wet hands with water and pour about 5 ml on the palm of hand.  Scrub thoroughly over all areas in both hands for at least 5 min., using a brush as needed.  Rinse thoroughly under running water.  Repeat as needed.

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scrubidinelabel.jpg

SCRUBIDINE   POVIDONE IODINE SURGICAL SCRUB
povidone iodine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12745-146
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	8.64 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM LAURYL SULFATE (UNII: 368GB5141J)	16.8 g  in 100 mL
LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)	1.08 g  in 100 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I)	0.311 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12745-146-01	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/03/1977
2	NDC: 12745-146-02	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/03/1977

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	08/03/1977	09/16/2019

Labeler - Medical Chemical Corporation (008496861)

Establishment
Name	Address	ID/FEI	Business Operations
Medical Chemical Corporation		008496861	manufacture(12745-146)

Revised: 9/2019

Document Id: 92b1c6b4-2fd0-14c0-e053-2a95a90a6372

34390-5

Set id: 095c47d5-9fe0-45ed-93eb-a2ac3961db59

Version: 11

Effective Time: 20190916

 

Medical Chemical Corporation