LIGHTS POVIDONE IODINE PREP PAD- povidone-iodine solution 
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.

----------

61333-203

Active Ingredient: Povidone-Iodine USP (10%)

Purpose: Antiseptic

Use:

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

Warnings:

For external use only

Do not use if allergic to iodine or in the eyes

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately

Ask a doctor before use if injuries are deep wounds, puncture wounds or serious burns

Stop use and ask a doctor if infection occurs or if redness, irritation, swelling, or pain persists or increases

Apply locally as need

Other information

Inactive Ingredient

Citric acid, purified water, Sodium phosphate dibasic

label

LIGHTS POVIDONE IODINE PREP PAD 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61333-203
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 (UNII: GR686LBA74)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61333-203-010.67 g in 1 POUCH; Type 0: Not a Combination Product10/15/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C10/15/2015
Labeler - Lights Medical Manufacture Co., Ltd. (529128649)
Registrant - Lights Medical Manufacture Co., Ltd. (529128649)
Establishment
NameAddressID/FEIBusiness Operations
Lights Medical Manufacture Co., Ltd.529128649manufacture(61333-203)

Revised: 3/2023
Document Id: f7e4f8db-7ae9-177a-e053-6294a90af792
Set id: e561332d-e419-43db-a68e-0c0d49b01c9a
Version: 5
Effective Time: 20230327
 
Lights Medical Manufacture Co., Ltd.