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


Just for you® ANTI-BACTERIAL HAND WIPE

ANTIBACTERIAL - 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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Just for you®
ANTI-BACTERIAL HAND WIPE

Drug Facts

Active Ingredient

Ethyl Alcohol 66.5%

Purpose

Antiseptic

Uses

  • for handwashing to decrease bacteria on skin when soap and water is not 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 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

  • tear open packet, remove towelette
  • wet hand/wrist area for 15 seconds and discard
  • supervise children under 6 years of age

Inactive ingredients

Aloe vera, fragrance, purified water, triethanolamine

SAFETEC OF AMERICA, Inc.
Buffalo, NY 14215
800-456-7077

PRINCIPAL DISPLAY PANEL – Anti-Bacterial Hand Wipe Label

NDC 61010-3112-0

Just for you®

ANTI-BACTERIAL HAND WIPE

Cleans and Sanitizes Hands

Use Before Each Meal

One [1] Wipe

PRINCIPAL DISPLAY PANEL – Anti-Bacterial Hand Wipe Label

ANTIBACTERIAL 
alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61010-3112
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:61010-3112-0 0.0019 L in 1 POUCH None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 05/02/2011

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

Revised: 05/2011 Safetec of America



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


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