LIGHTS POVINDONE IODINE SWABSTICK- povidone-iodine solution 
Lights Medical Manufacture Co., Ltd.

----------

Active Ingredient: Povidone-Iodine USP (10%)

Purpose: Antiseptic

Use:

Health care antiseptic for prepapration of skin prior to surgery.

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

Warnings:

For external use only

Do not *use or apply to the eyes *to individuals who are allergic or sensitive to iodine, *over large area of the body, *as first aid antiseptic longer than a week unless directed by a doctor 

Keep out of reach of children. If swallowed, get medical help or consult a poison control center immediately

Discontinue use if irritation and redness develop. Consult a doctor iin case of deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if infection occurs or if condition persists or increases

For preparation of the skin prior surgery: clean the affacted area, remove swabstick, apply to the operative site prior to surgery

For use as first aid antiseptic: clean the affacted area, apply a small anount of the product to the area 1-3 times daily. Maybe covered with a sterile bandage. If bandaged, let dry first.

Other information

Inactive Ingredient

Citric acid, purified water, Sodium phosphate dibasic

label

label

LIGHTS POVINDONE IODINE SWABSTICK 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61333-204
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61333-204-014.3 g in 1 POUCH; Type 0: Not a Combination Product03/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00303/01/2019
Labeler - Lights Medical Manufacture Co., Ltd. (529128649)
Registrant - Lights Medical Manufacture Co., Ltd. (529128649)
Establishment
NameAddressID/FEIBusiness Operations
Lights Medical Manufacture Co., Ltd.529128649manufacture(61333-204)

Revised: 11/2023
Document Id: 0b30b9da-c249-732f-e063-6394a90a2635
Set id: 2610fde4-4572-4d15-a970-f6d3beb734fe
Version: 4
Effective Time: 20231128
 
Lights Medical Manufacture Co., Ltd.