DRUG FACTS

Drug Labeling and Warnings

Drug Details [pdf]

POVIDONE-IODINE- povidone-iodine swab 
LernaPharm Loris Inc.

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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DRUG FACTS

Active Ingredients (in each Swab)

Povidone Iodine 10% w/v

Purpose

Antiseptic

Uses

First aid to reduce the risk of skin infection in minor cuts, scrapes and burns.

Warnings

For External Use only

OTC -Do Not Use Section

Do not use in the eyes ● Apply over a large areas of the body ● In case of deep puncture wounds, animal

bites, or serious burns, consult a doctor.

Other Required Warnings

Do not use longer than 1 week unless directed by the doctor.

OTC -Stop Use Section

Stop use and consult a doctor if the condition persists or gets worse.

Keep Out of Reach of Children

Keep Out of Reach of Children

Directions

● Clean the affected area ● Apply a small amount of this product on the area 1 to 3 times daily.

● May be covered with a sterile bandage ● If bandaged, let dry first.

Other Information

Store at room temperature between 59 - 86 0F (15 - 30 0C)

Inactive Ingredients

Purified water, sodium hydroxide solution, copovidone, glycerol, sodium lauryl sulfate, phosphorous, sodium citrate

Principal Display Panel

NDC: 68356-109-01                                                PRODUCT # 109-01U

LORIS 10% PVP - I SOLUTION

MEDIUM

200 Antiseptic swabs saturated with 10% W/V Povidone Iodine solution, USP

(equivalent to 1% available iodine)

200                                                  For external Use Only

POVIDONE-IODINE 
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68356-109
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	0.05 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
COPOVIDONE (UNII: D9C330MD8B)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
PHOSPHORUS (UNII: 27YLU75U4W)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68356-109-01	200 in 1 BOX; Type 0: Not a Combination Product	01/01/2011	09/19/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333	01/04/2010	09/19/2019

Labeler - LernaPharm Loris Inc. (206940905)

Establishment
Name	Address	ID/FEI	Business Operations
LernaPharm Loris Inc.		206940905	manufacture(68356-109)

Revised: 9/2019

Document Id: 9309836d-1381-21fe-e053-2995a90a6140

34390-5

Set id: 6296416a-6355-45e5-b2a5-c1e0ff2af57a

Version: 6

Effective Time: 20190921