LIGHTS POVIDONE IODINE SOLUTION- povidone-iodine solution

Lights Povidone Iodine Solution by

Drug Labeling and Warnings

Lights Povidone Iodine Solution by is a Otc medication manufactured, distributed, or labeled by Lights Medical Manufacture Co., Ltd., Lights Medical Manufacture Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Povidone-Iodine USP (10%)

PURPOSE

Purpose: Antiseptic

INDICATIONS & USAGE

Use: Antiseptic skin preparation

WARNINGS

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

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

ASK DOCTOR

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

DOSAGE & ADMINISTRATION

Apply locally as need

OTHER SAFETY INFORMATION

Other information

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

INACTIVE INGREDIENT

Inactive Ingredient

Disodium hydrogen phosphate, citric acid, water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIGHTS POVIDONE IODINE SOLUTION 
povidone-iodine solution

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

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

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

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

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

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

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

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