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Name:Antimicrobial Hand Wipe
Manufacturer:Sas Safety
Category:Over-the-counter (OTC) Marketed Drugs


FLU SHIELD ANTIMICROBIAL HAND WIPES

ANTIMICROBIAL HAND WIPE - alcohol cloth 
SAS Safety

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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FLU SHIELD ANTIMICROBIAL HAND WIPES

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 form fire or flame

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

Stop use and ask a 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
  • wipe hand/wrist areas for 15 seconds and discard
  • supervise children under 6 years of age

Inactive ingredients aloe vera, fragrance, purified water, triethanolamine

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL – POUCH

FLU SHIELD ANTIMICROBIAL HAND WIPES

Kills 99.99% of germs

1 premoistened towelette

For Professional Use

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL – POUCH

ANTIMICROBIAL HAND WIPE 
alcohol cloth
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65460-3111
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Alcohol (Alcohol) Alcohol .60 g
Inactive Ingredients
Ingredient Name Strength
Aloe  
water  
Product Characteristics
Color white (WHITE) Score     
Shape RECTANGLE (RECTANGLE) Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65460-3111-1 1 CLOTH (1 APPLICATOR) in 1 POUCH None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333 11/30/2009

Labeler - SAS Safety (122036627)
Registrant - Safetec (874965262)
Establishment
Name Address ID/FEI Operations
Safetec of America, Inc 874965262 MANUFACTURE

Revised: 11/2009 SAS Safety



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


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