POVIDONE-IODINE PREP PAD- povidone-iodine swab

POVIDONE-IODINE by

Drug Labeling and Warnings

POVIDONE-IODINE by is a Otc medication manufactured, distributed, or labeled by Carribbean Medical Brokers d.b.a. Specialty Medical Supplies , Specialty Medical Supplies Beijing. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Povidone Iodine USP 10% v/v

Purpose

Antiseptic

Uses

• Health Care Antiseptic for preparation of the skin prior to surgery
• First Aid Antiseptic to help prevent infection in minor cuts, scrapes and burns

Warnings

For external use only

Do not

• use in the eyes
• use on individuals who are allergic or sensitive to iodine
• apply over large areas of the body
• use as a first aid antiseptic for longer than 1 week unless directed by a doctor.

Discontinue use if irritation and redness develop.

Consult a doctor in case of

• deep or puncture wounds
• animal bites
• serious burns

Stop use and consult a doctor

If condition persists or gets worse.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

For preparation of the skin prior to surgery

• clean the affected area
• apply a small amount of this product to the area

For use as a first aid antispetic

• clean the affected area
• apply a small amount of the product on the area 1-3 times daily
• may be covered with a sterile bandage
• If bandaged, let dry first.

Other Information:

Store at room temperature: 59o -86o F (15o - 30o C)

Inactive Ingredients

citric acid, glycerin, Makon 8, purified water, sodium hydroxide

Package Label

Specialty Medical Supplies

Povidone Iodine Prep Pads Medium

For Individual, Professional and Hospital Use

Saturated with 10% Povidone Iodine for external use only

100 Individual Pads

Latex free

Two ply folded pad

10% Povidone Iodine for optimum bacterial action

Use for preparation of the skin prior to an injection;

to decrease germs in minor cuts and scrapes.

Four layer wrapper provides air-tight seal...

prevents leakage and drying out.

Manufactured by

Specialty Medical Supplies

Coral Springs, FL 33065

954-752-5603

www.specialtymedicalsupplies.com

Made in China

Specialty Medical Supplies

Povidone Iodine Prep Pads Medium

For Individual, Professional and Hospital Use

Saturated with 10% Povidone Iodine for external use only

200 Individual Pads

Latex free

Two ply folded pad

10% Povidone Iodine for optimum bacterial action

Use for preparation of the skin prior to an injection;

to decrease germs in minor cuts and scrapes.

Four layer wrapper provides air-tight seal...

prevents leakage and drying out.

Manufactured by

Specialty Medical Supplies

Coral Springs, FL 33065

954-752-5603

www.specialtymedicalsupplies.com

Made in China

INGREDIENTS AND APPEARANCE

POVIDONE-IODINE  PREP PAD
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68113-107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	0.10 g

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68113-107-01	100 in 1 PACKAGE
2	NDC: 68113-107-02	200 in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/11/2013

Labeler - Carribbean Medical Brokers d.b.a. Specialty Medical Supplies (018354907)

Registrant - Specialty Medical Supplies Beijing (527931082)

Establishment
Name	Address	ID/FEI	Business Operations
Specialty Medical Supplies Beijing		527931072	manufacture(68113-107)