Label: FIKES INSTANT HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 50036-515-80 - Packager: Fikes Northwest, Corp.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated July 21, 2010
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
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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.
- Directions
- Other Information
- Inactive Ingredients
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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 gelProduct 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