Hand Sanitizer Gel

Manufacturer
Nine Mile Health, LLC | Economy Polymers
Effective date
2020-07-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:26:36

Label at a glance#

ProductHand Sanitizer Gel
Active ingredientAlcohol
Label structure11 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use(s)

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame.

Do not use

OTC - DO NOT USE SECTION

  • In children less than 2 months of age
  • On open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

SPL UNCLASSIFIED SECTION

Manufactured by Economy Polymers and Chemicals
435 E Anderson Road, Houston, TX 77047

Distributed by Nine Mile Health, LLC
5500 Greenwood Plaza Blvd., Suite 130, Greenwood Village, CO 80111

PRINCIPAL DISPLAY PANEL - 3785 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NINE MILE
HEALTH

GEL

ALCOHOL ANTISEPTIC 80%
TOPICAL SOLUTION

1
GALLON
(3785 mL)
| NON-STERILE SOLUTION

PRINCIPAL DISPLAY PANEL - 3785 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 3785 mL Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78697-128-012022-01-28C16284748780-1d6a99b39-af2d-a426-e053-dadaa90af4c2Hand Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78697-128-01Hand Sanitizer Gel3785 mL in 1 BOTTLE, DISPENSINGLIQUID37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78697-128HAND SANITIZER GEL (ALCOHOL) LIQUID [NINE MILE HEALTH, LLC]1Legacy NDC, 1 package rows20200902_ff69736f-1a07-4e36-9b35-e510874b19b5.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78697-12878697-128-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5cee8121-9717-48d4-92f3-230cfb746229ff69736f-1a07-4e36-9b35-e510874b19b52020-07-07WarningsExact identifier
spl id: 5cee8121-9717-48d4-92f3-230cfb746229
spl set id: ff69736f-1a07-4e36-9b35-e510874b19b5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.