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Name:Nex Iodio P2
Manufacturer:Nex Medical S.a.s. Di Villa Annamaria & C.
Category:Over-the-counter (OTC) Marketed Drugs


Nex Iodio P2 Povidone-Iodine 5%

NEX IODIO P2  - povidone-iodine sponge 
Nex Medical S.A.S. di Villa Annamaria & C.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Nex Iodio P2 Povidone-Iodine 5%

Active Ingredients:
Povidone-Iodine   5 percent

Purpose
Antiseptic

Uses:
Significantly 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 or ears.
- Discontinue use if irritation or redness develops.
- Do not use otherwise than as directed

Keep out of reach of children.

Directions:

- Open package.

- Wet hands, forearms and sponge with water.

- Clean under nails with nail cleaner.
  Nails should be maintained with a 1 millimeter free edge.

- Scrub thoroughly for 3 minutes with sponge, paying particular
  attention to the nails, cuticles, and interdigital spaces.

- Rinse and repeat scrub. Discard nailcleaner and sponge after use.

- Rinse hands and forearms with running water.

Other Information:
Direct action towards gram-positive and gram-negative bacteria

Inactive Ingredients:
Purified Water, Sodium Hydroxide,
Sodium Laureth Sulfate, Sodium Phosphate Monobasic

NEX IODIO P2
Hospital and Professional Use Only

Surgical hand scrub/brush with
nailcleaner - POVIDONE IODINE 5%

Manufactured by: Nex Medical s.a.s., via Nievo 2, 20023 Cerro Maggiore (MI) - ITALY
Product of Italy

www.nexmedical.it
info@nexmedical.it

Sponge impregnated with 0.7 fl oz (20 ml) of Antiseptic Solution

Nex Iodio P2 5%


NEX IODIO P2 
povidone-iodine sponge
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50006-100
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POVIDONE-IODINE (POVIDONE-IODINE) POVIDONE-IODINE 5 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
SODIUM HYDROXIDE  
SODIUM LAURETH SULFATE  
SODIUM PHOSPHATE, MONOBASIC  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50006-100-05 20 mL in 1 PACKAGE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333 11/27/2009

Labeler - Nex Medical S.A.S. di Villa Annamaria & C. (433564874)
Registrant - Nex Medical S.A.S. di Villa Annamaria & C. (433564874)
Establishment
Name Address ID/FEI Operations
Nex Medical S.A.S. di Villa Annamaria & C. 433564874 manufacture

Revised: 11/2009 Nex Medical S.A.S. di Villa Annamaria & C.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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