FULL CARE POVIDONE IODINE PREP PAD- povidone-iodine solution
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.

----------

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

Keep out of reach of children.

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, Purified Water

label

FULL CARE POVIDONE IODINE PREP PAD
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65028-007
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	0.01 g in 1 mL

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
Packaging
1	NDC:65028-007-01	0.2 mL in 1 POUCH
2	NDC:65028-007-02	0.4 mL in 1 POUCH
3	NDC:65028-007-03	0.8 mL in 1 POUCH

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	10/17/2014

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(65028-007)