Smart San Hand Sanitizer Spray: Package Insert and Label Information

SMART SAN HAND SANITIZER SPRAY — ethanol liquid
Best Sanitizers, Inc

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.

Active Ingredient

Ethanol 71.0%

Purpose

Hand Sanitizer

Uses

  • Hand Sanitizer
  • Sanitize hands to help reduce bacteria that potentially can cause disease
  • Recommended for repeated use
  • Helps prevent drying of the skin

Warnings

  • For external use only
  • Flammable, keep away from fire or flame

When Using this product

  • Do not use in or near eyes.
  • For external use only
  • Discontinue use if irritation and redness develop If condition persists for more that 72 hours, consult a doctor.

Keep out of reach of children

In case of accidental ingestion seek medical attention or contact a poison center immediately.

Directions

  • Wet hands thoroughly with spray, covering entire surface of hands, especially the fingertips and cuticles
  • Rub hands together until dry.

Other Information

  • Store in a cool dry place below 104° F

Inactive ingredients

purified water, isopropanol, fragrance, glycerin, glycerol monolaurate

Questions?

Contact Best Sanitizers Mon-Fri 9am — 4pm PST at 888-225-3267

Principal Display Panel

NDC 59900-111-02

NDC 59900-111-03

NDC 59900-111-04

NDC 59900-111-05

NDC 59900-111-06

Smart San™ Hand Sanitizer Spray

Principal Display Panel
(click image for full-size original)
SMART SAN HAND SANITIZER SPRAY
ethanol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59900-111
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ethanol (Ethanol) Ethanol 710 g in 1000 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59900-111-02 3785 mL in 1 BOTTLE, PLASTIC None
2 NDC:59900-111-03 189250 mL in 1 DRUM None
3 NDC:59900-111-04 500 mL in 1 BOTTLE, PLASTIC None
4 NDC:59900-111-05 1000 mL in 1 BOTTLE, PLASTIC None
5 NDC:59900-111-06 59 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 07/01/2004
Labeler — Best Sanitizers, Inc (957473614)
Establishment
Name Address ID/FEI Operations
Best Sanitizers, Inc 627278224 manufacture

Revised: 03/2010 Best Sanitizers, Inc

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