POVIDONE IODINE SWABSTICKS- povidone-iodine swab
Shaoxing Fuqing Health Products 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
in the eyes

For external use only

Avoid "pooling" beneath patients.

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

For hospital or professional use only

Inactive Ingredient

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

image description

POVIDONE IODINE SWABSTICKS
povidone-iodine swab

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

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	03/30/2018

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

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

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