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

FULL CARE THREE POVIDONE IODINE SWABSTICKS (POVIDONE-IODINE) SWAB [SHAOXING FUQING HEALTH PRODUCTS CO., LTD.]
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NDC	65028-005-01, 65028-005-02
Set ID	546f18a1-4e8b-4f9f-8825-b96a715ff5ee
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

Avoid "pooling" beneath patients.
KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately
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, Water
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FULL CARE THREE POVIDONE IODINE SWABSTICKS
povidone-iodine swab

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	0.2 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERIN (UNII: PDC6A3C0OX)
NONOXYNOL-10 (UNII: K7O76887AP)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	09/12/2014

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(65028-005)

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Medic