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

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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61332-212

Active Ingredient: Povidone-Iodine USP (10%)

Equivalent to 1% titratable Iodine

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 right away

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, disodium phosphate, purified water

image description

LIGHTS POVINDONE IODINE SWABSTICK 
povidone-iodine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61333-212
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:61333-212-011 in 1 POUCH04/03/2023
11.5 g in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C04/03/2023
Labeler - Lights Medical Manufacture Co., Ltd. (529128649)
Registrant - Lights Medical Manufacture Co., Ltd. (529128649)
Establishment
NameAddressID/FEIBusiness Operations
Lights Medical Manufacture Co., Ltd.529128649manufacture(61333-212)

Revised: 4/2023
Document Id: f87aa328-0dd1-d119-e053-6394a90ae6a0
Set id: 977b6077-bf47-4e02-bde4-c752e73d7628
Version: 1
Effective Time: 20230403
 
Lights Medical Manufacture Co., Ltd.