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

FULL CARE POVIDONE IODINE SOLUTION (POVIDONE-IODINE) SOLUTION [SHAOXING FUQING HEALTH PRODUCTS CO., LTD.]
PDF | XML

NDC	65028-006-01, 65028-006-02, 65028-006-03, 65028-006-04, 65028-006-05, 65028-006-06, 65028-006-07
Set ID	ed1b3a11-bc63-4fbc-b7f2-5f95d9763592
Category	HUMAN OTC DRUG LABEL
Packager	Shaoxing Fuqing Health Products Co., Ltd.
Generic Name
Product Class
Product Number
Application Number	PART333C

View All Sections

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	1 g in 100 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:65028-006-01	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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	09/22/2014

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(65028-006)

View All Sections

Medic