povidine iodine by Dynarex Corporation POVIDINE IODINE swab

povidine iodine by

Drug Labeling and Warnings

povidine iodine by is a Otc medication manufactured, distributed, or labeled by Dynarex Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Povidone Iodine 10%                   

Purpose

Antiseptic

Use

• For preparation of the skin prior to surgery.
• First aid to help prevent infection in minor cuts, scrapes and burns.

Warnings:

For external use only

Do not use:

• In the eyes or over large areas of the body.
• longer than 1 week unless directed by doctor

Ask a doctor before use if you have:

deep or puncture wounds, animal bites or serious burns

Stop use and ask 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

• When preparing the skin prior to surgey, clean the area and apply product to operative site prior to surgery
• When used for first aid, clean the affected ared. Apply a small amount of this product on the area 1 to 3 times daily. Maybe covered with a sterile bandage. If bandaged, let dry first.

Other Iinformation:

Store at room temperature.

Avoid excessive heat

Inactive Ingredients

Citric acid, Glycerin, Polysorbate 80 (Tween 80), Sodium Citrate USP, Sodium Phosphate Dibasic, Water

Principal Display Panel

Reorder Number 1201

Povidone - Iodine Swabsticks

Antiseptic/Germicide

For External Use Only

dynarex

50 4'' saturated individual packets

INGREDIENTS AND APPEARANCE

POVIDINE IODINE 
povidine iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-419
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
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-419-01	0.3 mL in 1 PACKET; Type 0: Not a Combination Product	09/13/2016
2	NDC: 67777-419-02	0.9 mL in 1 PACKET; Type 0: Not a Combination Product	09/13/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	09/13/2016

Labeler - Dynarex Corporation (008124539)

Registrant - Dynarex Corporation (008124539)

Establishment
Name	Address	ID/FEI	Business Operations
Sion Biotext Mexico SAPI de CV		951575186	manufacture(67777-419)