ISODINE COPITOS- povidone-iodine solution

Isodine Copitos by

Drug Labeling and Warnings

Isodine Copitos by is a Otc medication manufactured, distributed, or labeled by Swabplus Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug FactsActive ingredient

Povidone iodine 10%, equal to 1% available Iodine

Purpose

Antiseptic

Uses First aid to help prevent infection due to minor cuts, scrapes and burns.

Keep out of reach of children

if swallowed, get medical help of contact a Poison Control Center right away.

Directions

• Hold the swab vertically, with the color ring tip upwards, Hold n the center of the tube with one hand at the color ring with the other.
• Gently snap the tip with the color ring, Formula inside the tube flows down and fills the opposite tip.
• Apply the product to the affected area.
• Discard swab after use.

Warnings

For external use only. Keep out of eyes and ear canal. Non-Sterile. Discontinue use if irritation.

Do not use. If you are sensitive to Iodine. Longer than one week unless directed by a doctor.

Stop use and ask a doctor. If you have deep or puncture wounds, or serious burns. redness, irritation, swelling or pain continue or increas., infedtion occurs.

Administration

For adults and children 2 and older: for minor wounds, burns and infections, apply directly to affected area. May be covered with a bandage.

Children under 2 years of age: Do not use, consult a doctor.

Other information: Store art room temperature, Avoid direct sunlight, excessive heat and moisture.

Inactive ingredients

Glycerin, water

Manufacturer Statement

Patented and manufactured by Swabplus Inc. Rancho Cucamonga, CA 91730 USA Made in USA

Imported and Distributed by Boehringer Ingelheim

Package and Labeling

Image of iodine carton label

INGREDIENTS AND APPEARANCE

ISODINE COPITOS  
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65734-511
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Povidone-Iodine (UNII: 85H0HZU99M) (Iodine - UNII:9679TC07X4)	Iodine	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Glycerin (UNII: PDC6A3C0OX)
Sodium Hydroxide (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	brown (dark)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65734-511-72	72 in 1 PACKAGE
1	NDC: 65734-511-00	0.15 mL in 1 APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	06/01/2008

Labeler - Swabplus Inc. (876441549)

Registrant - Swabplus Inc. (876441549)

Establishment
Name	Address	ID/FEI	Business Operations
Swabplus Inc.		876441549	manufacture(65734-511) , relabel(65734-511) , repack(65734-511)