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Name:Actigelhand Sanitizer
Manufacturer:Kay Chemical Company
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

ACTIGEL HAND SANITIZER - ethanol solution 
Kay Chemical Company

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 (in each use)

Ethanol, 60% by volume

Purpose

Antiseptic handwash

Uses

  • Antibacterial hand sanitizer

Warnings

  • For external use only
  • FLAMMABLE. Keep away from sparks and open flame.

Do not use

  • In eyes
  • On deep cuts or puncture wounds

When using this product

  • Discontinue use if irritation and redness develop

Stop use and ask a doctor if

  • Eye or skin irritation and redness persist for more than 72 hours

Keep out of reach of children.

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

Directions

  • Apply liberal amount into hand
  • Spread by rubbing hands together
  • Rub to dryness with attention to area around nails and between fingers

Other information

  • THIS PRODUCT IS NOT A SUBSTITUTE FOR HANDWASHING WITH SOAP AND WATER
  • For additional information, see Material Safety Data Sheet (MSDS)
  • For emergency medical information in the USA call 1 (800)304-0824 or call collect 0(303)592-1709

Inactive ingredients

water, isopropyl alcohol, acrylates/C10-C30 alkyl acrylate crosspolymer, triethanolamine, propylene glycol, myristyl alcohol

Questions?

Call 1-800-529-5458

Principal Display Panel/Representative Label

Kay

An Ecolab Company

Actigel

Hand Sanitizer

To obtain instruction in Spanish, see outer carton.

KAY CHEMICAL COMPANY

Greensboro, NC 27409-9790, USA

27 OZ (800 mL)

Representative label

ACTIGEL  HAND SANITIZER
ethanol, 60% by volume solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63146-301
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ETHANOL (ETHANOL) ETHANOL 60 mL  in 100 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63146-301-02 800 mL in 1 BAG None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333 05/26/2010

Labeler - Kay Chemical Company (003237021)

Revised: 05/2010 Kay Chemical Company



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


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