FIKES INSTANT HAND SANITIZER- alcohol gel

FIKES INSTANT HAND SANITIZER by

Drug Labeling and Warnings

FIKES INSTANT HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Fikes Northwest, Corp., Canberra Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Ethanol (60% v/v)

Purpose

Anti-Microbial Hand Sanitizer

Uses

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

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

• 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.

Other Information

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

Inactive Ingredients

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

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.

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