FULL CARE POVIDONE IODINE PREP PAD- povidone-iodine solution

Full Care Povidone Iodine Prep Pad by

Drug Labeling and Warnings

Full Care Povidone Iodine Prep Pad 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

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

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

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

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: 65028-007-01	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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	10/17/2014

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(65028-007)