FULL CARE POVIDONE IODINE SOLUTION- povidone-iodine solution

Full Care Povidone Iodine Solution by

Drug Labeling and Warnings

Full Care Povidone Iodine Solution 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% (1.0% Available Iodine)

PURPOSE

Purpose: Antiseptic

INDICATIONS & USAGE

Use: Prepping Intact Skin and Mucous Membranes Prior to Surgery

WARNINGS

Warnings:

For external use only

Avoid use on persons allergic to iodine

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or consult a poison control center right away

ASK DOCTOR

Stop use and ask a doctor if

• Skin shows symptoms of irritation, sensitivity, redness, pain, or swelling.

DOSAGE & ADMINISTRATION

Directions: Patient Preoperative Prep:

Use full strength. Apply solution to preoperative site following povidone iodine scrub application. Use a circular motion,start as incision site and move onward. Remove all soiled underdrapes. Do not allow solution to pool.

OTHER SAFETY INFORMATION

Other information

• Store at room temperature.
• Avoid excessive heat (above 104F/40C)
• Protect from freezing)
• Laetx free

INACTIVE INGREDIENT

Inactive Ingredient

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FULL CARE POVIDONE IODINE SOLUTION 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65028-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	1 g  in 100 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: 65028-006-01	59 mL in 1 BOTTLE
2	NDC: 65028-006-02	88.5 mL in 1 BOTTLE
3	NDC: 65028-006-03	109 mL in 1 BOTTLE
4	NDC: 65028-006-04	50 mL in 1 BOTTLE
5	NDC: 65028-006-05	100 mL in 1 BOTTLE
6	NDC: 65028-006-06	150 mL in 1 BOTTLE
7	NDC: 65028-006-07	200 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	09/22/2014

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(65028-006)