FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
One Plastic ATX s de RL de CV
Effective date
2020-08-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:26:15

Label at a glance#

ProductHand 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) (70%, 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. Carbopol (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 70% 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, Carbopol, Purified water USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

150 ml150 ml150ml NDC 80354-830-01

300 ml300 ml

300ml NDC 80354-830-02

500 ml500 ml

500 ml NDC 80354-830-03

600 ml600 ml

600 ml NDC 80354-830-04

1000 ml1000 ml

1000 ml NDC 80354-830-05

1500 ml1500 ml

1500 ml NDC 80354-830-06

3750 ml3750 ml

3750 ml NDC 80354-830-07

18750 ml18750 ml

18750 ml NDC 80354-830-08

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80354-830-012022-01-28C16284748780-1d6a99b39-464f-a426-e053-dadaa90af4c2adf3f47b-ce52-987e-e053-2a95a90a4d84
80354-830-022022-01-28C16284748780-1d6a99b39-464f-a426-e053-dadaa90af4c2adf3f47b-ce52-987e-e053-2a95a90a4d84
80354-830-032022-01-28C16284748780-1d6a99b39-464f-a426-e053-dadaa90af4c2adf3f47b-ce52-987e-e053-2a95a90a4d84
80354-830-042022-01-28C16284748780-1d6a99b39-464f-a426-e053-dadaa90af4c2adf3f47b-ce52-987e-e053-2a95a90a4d84
80354-830-052022-01-28C16284748780-1d6a99b39-464f-a426-e053-dadaa90af4c2adf3f47b-ce52-987e-e053-2a95a90a4d84
80354-830-062022-01-28C16284748780-1d6a99b39-464f-a426-e053-dadaa90af4c2adf3f47b-ce52-987e-e053-2a95a90a4d84
80354-830-072022-01-28C16284748780-1d6a99b39-464f-a426-e053-dadaa90af4c2adf3f47b-ce52-987e-e053-2a95a90a4d84
80354-830-082022-01-28C16284748780-1d6a99b39-464f-a426-e053-dadaa90af4c2adf3f47b-ce52-987e-e053-2a95a90a4d84

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80354-830-01Hand Sanitizer150 mL in 1 BOTTLEGEL1501
80354-830-02Hand Sanitizer300 mL in 1 BOTTLEGEL3001
80354-830-03Hand Sanitizer500 mL in 1 BOTTLEGEL5001
80354-830-04Hand Sanitizer600 mL in 1 BOTTLEGEL6001
80354-830-05Hand Sanitizer1000 mL in 1 BOTTLEGEL10001
80354-830-06Hand Sanitizer1500 mL in 1 BOTTLEGEL15001
80354-830-07Hand Sanitizer3750 mL in 1 BOTTLEGEL37501
80354-830-08Hand Sanitizer18750 mL in 1 BOTTLEGEL187501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80354-830HAND SANITIZER (ALCOHOL) GEL [ONE PLASTIC ATX S DE RL DE CV]1Legacy NDC, 8 package rows20200829_adf3f47b-ce52-987e-e053-2a95a90a4d84.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
80354-83080354-830-01, 80354-830-02, 80354-830-03, 80354-830-04, 80354-830-05, 80354-830-06, 80354-830-07, 80354-830-08

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
adf41980-1059-7c4a-e053-2a95a90a1244adf3f47b-ce52-987e-e053-2a95a90a4d842020-08-28WarningsExact identifier
spl id: adf41980-1059-7c4a-e053-2a95a90a1244
spl set id: adf3f47b-ce52-987e-e053-2a95a90a4d84

Reported adverse events (FAERS/openFDA)#

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