POVIDONE IODINE SWABSTICKS- povidone-iodine swab

Povidone Iodine Swabsticks by

Drug Labeling and Warnings

Povidone Iodine Swabsticks by is a Otc medication manufactured, distributed, or labeled by Shaoxing Fuqing Health Products Co., Ltd., Shaoxing Fuqing Health Products 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
• in the eyes

For external use only

Avoid "pooling" beneath patients.

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

• For hospital or professional use only

INACTIVE INGREDIENT

Inactive Ingredient

Citric Acid, Glycerin, Nonoxyol-10, Sodium Hydroxide, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

POVIDONE IODINE SWABSTICKS 
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65028-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	0.2 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERIN (UNII: PDC6A3C0OX)
NONOXYNOL-10 (UNII: K7O76887AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65028-008-01	3 in 1 POUCH; Type 0: Not a Combination Product	03/30/2018
2	NDC: 65028-008-02	1 in 1 POUCH; Type 0: Not a Combination Product	03/30/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	03/30/2018

Labeler - Shaoxing Fuqing Health Products Co., Ltd. (530545003)

Registrant - Shaoxing Fuqing Health Products Co., Ltd. (530545003)

Establishment
Name	Address	ID/FEI	Business Operations
Shaoxing Fuqing Health Products Co., Ltd.		530545003	manufacture(65028-008)