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Name:Betadinesurgical Scrub
Manufacturer:Purdue Products Lp
Category:Over-the-counter (OTC) Marketed Drugs


Betadine Surgical ScrubPovidone-iodine, 7.5%

BETADINE SURGICAL SCRUB - povidone-iodine solution 
Purdue Products LP

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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Betadine Surgical Scrub

Povidone-iodine, 7.5%

Drug Facts

Active ingredient

Povidone-iodine, 7.5% (0.75% available iodine)

Purpose

Antiseptic

Uses

  • for preparation of the skin prior to surgery
  • helps to reduce bacteria that potentially can cause skin infection
  • for handwashing to reduce bacteria on the skin
  • significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care

Warnings

For external use only

Do not use this product

  • in the eyes

Stop use and ask a doctor

  • if irritation and redness develop
  • in rare instances of local irritation or sensitivity

When using this product

  • prolonged exposure to wet solution may cause irritation or, rarely, severe skin reactions
  • in pre-operative prepping, avoid “pooling” beneath the patient

Keep out of reach of children.

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

Directions

  1. Surgical hand scrub:
    • wet hands with water
    • spread about 5 cc (1 teaspoonful) of Scrub over both hands and forearms
    • without adding more water, scrub thoroughly for 2 1/2 to 3 minutes
    • use a sponge if desired. Clean thoroughly under fingernails.
    • add a little water and develop copious suds. Rinse thoroughly under running water.
    • repeat the entire procedure using another 5 cc of Scrub
  2. Antiseptic hand wash:
    • wet hands with water and pour about 5 cc of Scrub on hands
    • rub hands vigorously together for at least 15 seconds, covering all surfaces
    • rinse and dry with a disposable towel
  3. Patient pre-operative skin preparation:
    • wet skin with water
    • apply Scrub (1 cc is sufficient to cover an area of 20-30 square inches), develop lather and scrub thoroughly for about 5 minutes
    • rinse off using sterile gauze saturated with water
    • the area may then be painted with BETADINE Solution and allowed to dry

Other information

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • store in original container

Inactive ingredients

ammonium nonoxynol-4 sulfate, nonoxynol-9, purified water, sodium hydroxide

2008, Purdue Products L.P.

Dist. by: Purdue Products L.P.
Stamford, CT 06901-3431

L01068B 301013-0C

Betadine Surgical Scrub
NDC 67618-150-17

Betadine Surgical Scrub NDC 67618-150-17

BETADINE  SURGICAL SCRUB
povidone-iodine solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67618-151
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POVIDONE-IODINE (POVIDONE-IODINE) POVIDONE-IODINE .075 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
SODIUM HYDROXIDE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67618-151-04 118 mL in 1 BOTTLE None
2 NDC:67618-151-16 473 mL in 1 BOTTLE None
3 NDC:67618-151-17 473 mL in 1 BOTTLE None
4 NDC:67618-151-32 946 mL in 1 BOTTLE None
5 NDC:67618-151-01 3780 mL in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 06/15/1980

Labeler - Purdue Products LP (141916531)
Establishment
Name Address ID/FEI Operations
Thatcher Company 041307356 MANUFACTURE

Revised: 01/2011 Purdue Products LP



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


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