LIGHTS POVINDONE IODINE SWABSTICK- povidone-iodine solution

Lights Povindone Iodine Swabstick by

Drug Labeling and Warnings

Lights Povindone Iodine Swabstick 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:

Health care antiseptic for prepapration of skin prior to surgery.

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

WARNINGS

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

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

ASK DOCTOR

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

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

Other information

• Store at room temperature

INACTIVE INGREDIENT

Inactive Ingredient

Citric acid, purified water, Sodium phosphate dibasic

label

INGREDIENTS AND APPEARANCE

LIGHTS POVINDONE IODINE SWABSTICK 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61333-204
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61333-204-01	4.3 g in 1 POUCH; Type 0: Not a Combination Product	03/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	03/01/2019

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(61333-204)