LIGHTS POVIDONE IODINE SOLUTION- 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.

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Active Ingredient: Povidone-Iodine USP (10%)

Purpose: Antiseptic

Use: Antiseptic skin preparation

Warnings:

Do not use if allergic to iodine

For external use only

Do not use in eyes

Avoid "pooling" beneath patients. Prolonged exposure to wet solution may cause skin irritation

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 or puncture wounds
serious burns

Stop use and ask a doctor if

redness, irritation, swelling, or pain persists or increases
infection occurs

Apply locally as need

Other information

1% available iodine
latex free
for hospital or professional use only

Inactive Ingredient

Disodium hydrogen phosphate, citric acid, water

label

LIGHTS POVIDONE IODINE SOLUTION
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61333-201
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	1.18 g in 118 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61333-201-01	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/04/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	02/22/2014

Labeler - Lights Medical Manufacture Co., Ltd. (529128649)

Registrant - Lights Medical Manufacture Co., Ltd. (529128649)

Name	Address	ID/FEI	Business Operations
Establishment
Lights Medical Manufacture Co., Ltd.		529128649	manufacture(61333-201)