Fikes Instant Hand Sanitizer
FDA Label NDC 50036-515

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Fikes Northwest, Corp. for the product Fikes Instant Hand Sanitizer (NDC 50036-515). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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.

    Principal Display Panel (FIKES Instant Hand Sanitizer)

    Principal Display Panel (FIKES Instant Hand Sanitizer)

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