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Name:Antimicrobial
Manufacturer:Safetec Of America
Category:Over-the-counter (OTC) Marketed Drugs


Antimicrobial

ANTIMICROBIAL - alcohol liquid 
Safetec of America

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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Antimicrobial

Drug Facts

Active ingredients

Ethyl Alcohol 66.5%

Purpose

Antiseptic

Uses

  • for handwashing to decrease bacteria on skin whenever soap and water is not readily available

Warnings

For external use only. Flammable, keep away from fire or flame

Do not use in the eyes. If this happens, rinse thoroughly with water.

Stop use and ask doctor if

  • irritation or redness develop and persists 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

  • wet hands and wrists thoroughly for 15 seconds and allow to air dry
  • always reseal after use
  • children under 6 years of age should be supervised when using this product

Inactive ingredients

Aloe vera, fragrance, purified water, triethanolamine

SAFETEC OF AMERICA, Inc.
887 Kensington Ave. Buffalo, NY 14215
800-456-7077 www.safetec.com

Reorder no. 34421
275 Gal. (1,041 L)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL – 275 Gallon Container Label

NDC 61010-3200-0

Safetec

p.a.w.s.

Antimicrobial Liquid

  • Kills 99.9% of Germs!
  • Contains 66.5% Ethyl Alcohol
  • Enriched with Aloe Vera

Citrus Scent

SAFETEC OF AMERICA, Inc.

887 Kensington Ave. Buffalo, NY 14215

800-456-7077 www.safetec.com

Reorder no. 34421

275 Gal. (1,041 L)

PRINCIPAL DISPLAY PANEL – 275 Gallon Container Label

ANTIMICROBIAL 
alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61010-3200
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
alcohol (alcohol) alcohol 665 mL  in 1 L
Inactive Ingredients
Ingredient Name Strength
aloe  
water  
trolamine  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61010-3200-0 1041 L in 1 CONTAINER None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 03/07/2011

Labeler - Safetec of America (874965262)
Establishment
Name Address ID/FEI Operations
Safetec of America, Inc. 874965262 MANUFACTURE

Revised: 03/2011 Safetec of America



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


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