Atmosphere Hand Sanitizer

Manufacturer
Atmosphere Global LLC | MaxPax LLC | WholeChem LLC | Hocking International lab
Effective date
2021-01-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:36:31

Label at a glance#

ProductAtmosphere Hand Sanitizer
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

Atmosphere Hand Sanitizer

Alcohol Antiseptic 80%

Topical Solution

Hand Sanitizer

Non-Sterile Solution

XXmL (X fl oz)

Made in USA

Atmosphere Global LLC

55 W Goethe St,

Chicago IL 60610, USA

www.atmosphereglobal.com

Emergency number: 800-535-5053

Hand Sanitizer-12_16ozHand Sanitizer-12_16oz

Hand Sanitizer 16ozHand Sanitizer 16oz

Hand sanitizer Label 1GHand sanitizer Label 1G

Hand sanitizer label 4x1gHand sanitizer label 4x1g

Hand sanitizer 36 cases of 4x1gHand sanitizer 36 cases of 4x1g

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN3
1039339ethanol 0.8 ML/ML Topical SolutionSCD3
1039339ethanol 80 % Topical SolutionSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77028-001-262022-07-29C16284748780-1e4f33bdf-ad56-d8a0-e053-dadaa90a6e4eDrug Facts
77028-001-362022-07-29C16284748780-1e4f33bdf-ad56-d8a0-e053-dadaa90a6e4eDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77028-001-01Atmosphere Hand Sanitizer3785 mL in 1 BOTTLELIQUID37853
77028-001-16Atmosphere Hand Sanitizer473 mL in 1 BOTTLE, SPRAYLIQUID4733
77028-001-26Atmosphere Hand Sanitizer12 in 1 BOXLIQUID123
77028-001-36Atmosphere Hand Sanitizer144 in 1 BOXLIQUID1443
77028-001-41Atmosphere Hand Sanitizer4 in 1 CASELIQUID43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77028-001ATMOSPHERE HAND SANITIZER (ALCOHOL) LIQUID [ATMOSPHERE GLOBAL LLC]3Legacy NDC, 5 package rows20210107_a53a9cba-e6c9-6c08-e053-2995a90adc79.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
77028-00177028-001-01, 77028-001-41, 77028-001-36, 77028-001-16, 77028-001-26

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
b83f52e5-adc7-2ab5-e053-2995a90a9d83a53a9cba-e6c9-6c08-e053-2995a90adc792021-01-06WarningsExact identifier
spl id: b83f52e5-adc7-2ab5-e053-2995a90a9d83
spl set id: a53a9cba-e6c9-6c08-e053-2995a90adc79

Reported adverse events (FAERS/openFDA)#

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