Full Care Povidone Iodine Prep Pad (Povidone-Iodine) Solution [Shaoxing Fuqing Health Products Co., Ltd.] -

FULL CARE POVIDONE IODINE PREP PAD (POVIDONE-IODINE) SOLUTION [SHAOXING FUQING HEALTH PRODUCTS CO., LTD.]
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NDC	65028-007-01, 65028-007-02, 65028-007-03
Set ID	7902534b-2cb7-44f0-856d-f42d84b66894
Category	HUMAN OTC DRUG LABEL
Packager	Shaoxing Fuqing Health Products Co., Ltd.
Generic Name
Product Class
Product Number
Application Number	PART333C

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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
KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.
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, Purified Water
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FULL CARE POVIDONE IODINE PREP PAD
povidone-iodine solution

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)

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Medic