Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

DIGISAN- alcohol aerosol, foam 
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

Ethyl alcohol, 62.5% by volume

Purpose

Antiseptic Handwash

Uses

• Antiseptic Foam Hand Rinse
  

Warnings

• For external use only
• FLAMMABLE.  Keep away from fire or flame, heat, sparks, and sources of static discharge
• Contents under pressure.  Do not store at temperatures above 120 o F (48 o C), puncture or incinerate
• Operate only with spout pointing down
  

Do not use

• In eyes
  

When using this product

• If in eyes, rinse promptly and thoroughly with water
• Discontinue use if irritation and redness develop
  

Stop use and ask a physician if skin irritation or redness occurs for more than 72 hours

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

Directions

• Spread thoroughly onto hands and rub until dry.
  

Other Information

• For additional information, see Material Safety Data Sheet (MSDS)
• For emergency medical information in USA and Canada, call 1-800-328-0026
• For emergency medical information worldwide, call 1-651-222-5352 (in the USA)
  

Inactive ingredients:  water, isobutane, glycerin, cetearyl alcohol, hydrofluorocarbon 152A, propane, polysorbate-60, sodium lauroyl lactylate, steareth-20, sodium benzoate.

Questions?  Call 1-800-35-CLEAN (352-5326).

Principal display panel and representative label

ECOLAB

NDC: 47593-409-87

DigiSan Healthcare Hand Sanitizer Foam

Active Ingredient:  62.5% Ethyl Alcohol

DIGITS

Net Weight:  15 oz/425 g

DIGISAN 
alcohol aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47593-409
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOBUTANE (UNII: BXR49TP611)
GLYCERIN (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
1,1-DIFLUOROETHANE (UNII: 0B1U8K2ME0)
PROPANE (UNII: T75W9911L6)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
STEARETH-20 (UNII: L0Q8IK9E08)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47593-409-87	425 g in 1 CAN; Type 0: Not a Combination Product	10/31/2003	07/17/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	10/31/2003	07/17/2019

Labeler - Ecolab Inc. (006154611)

Revised: 7/2019

Document Id: 8a8f294c-2611-43f0-ac11-8577302b41a2

34390-5

Set id: 31e75992-4491-4273-9108-48c2b59ad5fa

Version: 3

Effective Time: 20190717