BETADINE SURGICAL SCRUB- povidone-iodine solution 
Atlantis Consumer Healthcare, Inc.

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Betadine Surgical Scrub

Drug Facts


Active ingredient

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

Purpose

Antiseptic

Uses

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

Warnings

For external use only

Do not use this product

  • in the eyes

When using this product

  • prolonged exposure to wet solution may cause irritation or, rarely, severe skin reactions

Stop use and ask a doctor

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

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 handsand forearms
    • without adding more water, scrub thoroughly for 2 1/2 to3 minutes
    • use a sponge if desired. Clean thoroughly under fingernails.
    • add a little water and develop copious suds. Rinse thoroughlyunder 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, coveringall surfaces
    • rinse and dry with a disposable towel

Other information

Inactive ingredients

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

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

304954-0A

Betadine Surgical Scrub
NDC 67618-151-17

NDC 67618-150-17
BETADINE  SURGICAL SCRUB
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-151
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE.075 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67618-151-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/1996
2NDC:67618-151-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/199601/31/2025
3NDC:67618-151-171 in 1 CARTON07/01/199601/31/2025
3473 mL in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:67618-151-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/199611/30/2024
5NDC:67618-151-013780 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/1996
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00307/01/1996
Labeler - Atlantis Consumer Healthcare, Inc. (118983925)
Registrant - Atlantis Consumer Healthcare, Inc. (118983925)

Revised: 12/2023
Document Id: d2837dd9-1ba2-4a6d-a1a5-06ea00a62a1d
Set id: 1ad39e11-ea1e-44a4-8224-93f8135436c2
Version: 9
Effective Time: 20231222
 
Atlantis Consumer Healthcare, Inc.