DrugCite

BETADINE SURGICAL SCRUB - povidone-iodine solution 
Purdue Products LP

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 NDC Product Code (Source) 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
# NDC Package Description Multilevel Packaging
1 67618-151-04 118 mL In 1 BOTTLE None
2 67618-151-16 473 mL In 1 BOTTLE None
3 67618-151-17 473 mL In 1 BOTTLE None
4 67618-151-32 946 mL In 1 BOTTLE None
5 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: 01/2011Purdue Products LP