ANTISEPTIC PATIENT PREOPERATIVE SKIN PREPARATION AND SURGICAL HAND SCRUB- povidone-iodine solution

Antiseptic Patient Preoperative Skin Preparation and Surgical Hand Scrub by

Drug Labeling and Warnings

Antiseptic Patient Preoperative Skin Preparation and Surgical Hand Scrub by is a Otc medication manufactured, distributed, or labeled by Degasa SA De CV, Degasa, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Povidone Iodine 7.5%

Purpose

Antiseptic

Uses

Patient preoperative skin preparation:

• For preparation of the skin prior to surgery
• Helps reduce bacteria that potentially can cause skin infection

Surgical hand scrub:

• Significantyl reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care

WARNINGS: For External Use Only

Do not use

• In the eyes
• Heat prior to application
• On individuals who are allergic or sensitive to Iodine

Stop use and ask a doctor if

• Irritation and redness develop
• If condition persists for more than 72 hous consult a doctor

Keep out of reach of children

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

Directions

Patient preoperative skin preparation:

• Clean the area
• Apply product to the operative site prior to surgery
• Scrub thoroughly for 5 minutes
• Rinse off with a sterile gauze saturated with water

Surgical hand scrub:

• Clean under nails with a nail pick. Nail should be maintained with a 1 millimeter free edge
• Wet hands and forearms
• Apply 5 millileters (teaspoonful) or palmfull to hands and forearms
• Scub thoroughly for 5 minutes with a sterile brush
• Paying particular attention to the nails, cuticles, and interdigital spaces
• Rinse and repeat scrub

Other information

Store at room temperature 20-25°C (68-77°F)

Inactive Ingredients

Disodium Phosphate, Glycerin, Hidroxyethylcellulose, Monoethanolamine, Dionized Water

Package Labeling

INGREDIENTS AND APPEARANCE

ANTISEPTIC PATIENT PREOPERATIVE SKIN PREPARATION AND SURGICAL HAND SCRUB 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67326-352
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
GLYCERIN (UNII: PDC6A3C0OX)
MONOETHANOLAMINE (UNII: 5KV86114PT)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67326-352-07	48 in 1 CASE	08/13/2015
1		59 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 67326-352-08	48 in 1 CASE	08/13/2015
2		118 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 67326-352-06	24 in 1 CASE	08/13/2015
3		237 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 67326-352-03	24 in 1 CASE	08/13/2015
4		474 mL in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 67326-352-05	12 in 1 CASE	08/13/2015
5		948 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/13/2015

Labeler - Degasa SA De CV (812771980)

Establishment
Name	Address	ID/FEI	Business Operations
Degasa, S.A. de C.V.		812771980	manufacture(67326-352)