Hand Sanitizer Hydrogel

Manufacturer
Smokecrossroads Vapor
Effective date
2020-07-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:24:34

Label at a glance#

ProductHand Sanitizer WHO
Active ingredientALCOHOL
Label structure13 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

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

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 eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WHO 1900mLWHO 1900mLGEL 1900 mLGEL 1900 mL30 mL NDC: 90066-9664-1 GEL 1ozGEL 1oz

120 mL NDC: 90066-9664-2 GEL 4ozGEL 4oz

4ozeucalptusmintlabel4ozeucalptusmintlabel

4ozlavendermintlabel4ozlavendermintlabel

4ozcoconutlemongrasslabel4ozcoconutlemongrasslabel

4oz cucumber aloe vera4oz cucumber aloe vera

250mL NDC 90066-9664-3 GEL 8.5oz 250mlGEL 8.5oz 250ml

500mL NDC 90066-9664-4 GEL 16ozGEL 16oz

1900 mL NDC; 90066-9664-5

3800 mL NDC: 90066-9664-6 GEL GallonGEL Gallon

120mL NDC 90066-4934-1 WHO 4ozWHO 4oz

1900 mL NDC: 90066-4934-2

3800 mL NDC: 90066-4934-3 WHO 3800WHO 3800

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
90066-4934-1Hand Sanitizer WHO120 mL in 1 BOTTLE, SPRAYLIQUID1201
90066-4934-2Hand Sanitizer WHO1900 mL in 1 JUGLIQUID19001
90066-4934-3Hand Sanitizer WHO3800 mL in 1 JUGLIQUID38001
90066-9664-1Hand Sanitizer Hydrogel0.03 L in 1 BOTTLE, PLASTICGEL0.031
90066-9664-2Hand Sanitizer Hydrogel0.12 L in 1 BOTTLE, PLASTICGEL0.121
90066-9664-3Hand Sanitizer Hydrogel0.251 L in 1 BOTTLE, PUMPGEL0.2511
90066-9664-4Hand Sanitizer Hydrogel0.5 L in 1 BOTTLE, PUMPGEL0.51
90066-9664-5Hand Sanitizer Hydrogel1.9 L in 1 JUGGEL1.91
90066-9664-6Hand Sanitizer Hydrogel3.8 L in 1 JUGGEL3.81

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
90066-4934HAND SANITIZER WHO (ALCOHOL) LIQUID HAND SANITIZER HYDROGEL (ALCOHOL) GEL [SMOKECROSSROADS VAPOR]1Legacy NDC, 3 package rows20200813_ab8342f5-d5dd-4db2-e053-2a95a90a30f5.zip
90066-9664HAND SANITIZER WHO (ALCOHOL) LIQUID HAND SANITIZER HYDROGEL (ALCOHOL) GEL [SMOKECROSSROADS VAPOR]1Legacy NDC, 6 package rows20200813_ab8342f5-d5dd-4db2-e053-2a95a90a30f5.zip

Products#

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NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
ab8342f5-d5cf-4db2-e053-2a95a90a30f5ab8342f5-d5dd-4db2-e053-2a95a90a30f52020-07-28WarningsExact identifier
spl id: ab8342f5-d5cf-4db2-e053-2a95a90a30f5
spl set id: ab8342f5-d5dd-4db2-e053-2a95a90a30f5

Reported adverse events (FAERS/openFDA)#

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