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Name:Alphadine Scrub Foamantimicrobial Foam
Manufacturer:Ecolab Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

ALPHADINE SCRUB FOAM ANTIMICROBIAL FOAM - iodine solution 
Ecolab Inc.

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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Drug Facts

Active ingredient

Povidone Iodine, 7.5%

Purposes

Surgical hand scrub

General skin cleanser

Uses

  • significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care
  • general skin cleansing to help reduce bacteria on the skin

Warnings

  • For external use only

Do not use

  • In eyes

When using this product

  • if eye contact occurs, rinse promptly and thoroughly with water

Stop use and ask a doctor if skin irritation and redness persist for more than 72 hours.

Keep out of reach of children.  If swallowed, get medical help or contact Poison Control Center right away.

Directions

Surgical scrub

  • remove jewelry
  • clean nails with an orangewood stick
  • wet hands and forearms with water and apply 5 grams (egg size) of Alphadine Scrub Foam
  • wash/scrub hands and forearms for 5 minutes paying particular attention to nails, cuticles, and interdigital spaces
  • rinse thoroughly with water
  • wet hands and forearms with water and apply 5 grams (egg size) of Alphadine Scrub Foam
  • wash hands and forearms for 5 minutes
  • rinse thoroughly with water
_________________________________________________________________________________________________________________________________________________________________

General skin cleansing

  • apply the minimum amount of product necessary to cover the skin and wash gently and thoroughly with water
  • rinse again thoroughly

Other information

  • For emergency medical information in USA and Canada, call 1-800-328-0026

Inactive ingredients  ammonium nonoxynol-4 sulfate, sodium citrate, water

Principal Display Panel/Representative Label

Huntington brand

SKIN CARE

NDC 47593-173-36

DIN 02039613

Alphadine Scrub Foam

Antimicrobial Foam

Active ingredient:  Povidone Iodine, 7.5%

ECOLAB

Net Contents:  27 oz/800 mL

Ecolab Healthcare Division

370 Wabasha St N., St. Paul MN 55102

5105 Tomken Road, Mississauga,

Ont., Caanada L4W 2X5



Representative label


ALPHADINE SCRUB FOAM  ANTIMICROBIAL FOAM
surgical hand scrub, general skin cleanser solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:47593-173
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Iodine (Iodine) Iodine 7.5 mL  in 100 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47593-173-36 800 mL in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333 02/05/2000

Labeler - Ecolab Inc. (006154611)

Revised: 12/2009 Ecolab Inc.



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


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