Available Formats

• SPL UNCLASSIFIED SECTION

  Drug Facts

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• Active Ingredient

  Ethanol (60% v/v)

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• Purpose

  Anti-Microbial Hand Sanitizer

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• Uses

  • Helps reduce bacteria that potentially can cause disease
  • Helps prevent cross contamination by hand contact
  • Recommended for repeated use

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• Warnings

  • For external use only
  • Flammable, keep away from fire, heat, or flame
  • Keep out of reach of children.
  • Do not use near eyes
  • In case of eye contact flush with water for 15 minutes
  • If irritation persists stop use of product and get medical attention
  • In case of accidental ingestion seek medical attention or contact a poison control center immediately.

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• Directions

  • Use no water or towels
  • Apply appropriate amount of product to palm of hand
  • Rub until hands are completely covered
  • Agitate lightly until dry
  • Let air dry for 15 seconds
  • Do not rinse or wipe with towel.

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• Other Information

  • Store in a cool dry place below 104° F.

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• Inactive Ingredients

  Water, Carbomer, Triethanolamine, PEG-75 Lanolin, Aloe Vera Gel, Fragrance.

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• Principal Display Panel

  FIKES

  Instant Hand Sanitizer

  (Gel-Type)

  • Enhanced with Moisturizers
  • Kills disease causing germs within seconds
  • Effective against MRSA, VRE, E. coli (0157:H7) Staphylococcus, Streptococcus and other organisms
  • Assists with OSHA Bloodborne Pathogen Standard Compliance

  See Drug Facts panel for additional information

  For Hospital and Professional Use Only

  Align the half moon ears (round side out) with

  the slots of the dispenser's lower docking area.

  Press top and bottom of tube firmly into place.

  

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• INGREDIENTS AND APPEARANCE

  FIKES INSTANT HAND SANITIZER  alcohol gel

  Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50036-515 Route of Administration TOPICAL

  Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M) alcohol 600 mL  in 1000 mL

  Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R)   carbomer homopolymer type c (UNII: 4Q93RCW27E)   aloe (UNII: V5VD430YW9)   trolamine (UNII: 9O3K93S3TK)

  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50036-515-80 800 mL in 1 BAG

  Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333 07/21/2010

  Labeler - Fikes Northwest, Corp. (167376284)

  Establishment
  Name	Address	ID/FEI	Business Operations
  Canberra Corporation		068080621	MANUFACTURE

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