FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Pinturas y Recubrimientos Ravtech, S.A. de C.V. | Mario Hidalgo
Effective date
2020-10-14
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-05-31 23:31:37

Label at a glance#

ProductPure Army Hand Sanitizer
Active ingredientALCOHOL
Label structure16 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#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol Ethyl 75% 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

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 1000000 mL Liq.Label 1000000 mL Liq.1000000 mL Liq. NDC: 78177-347-26

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 500 mL LiquidLabel 500 mL Liquid500 mL Liq. NDC: 78177-347-22

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 1000 mL Liq.Label 1000 mL Liq.1000 mL Liq. NDC: 78177-347-24

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4000 mL Liq. NDC: 78177-347-23 Label 4000 mL Liq.Label 4000 mL Liq.

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 20000 mL Liq.Label 20000 mL Liq.20000 mL Liq. NDC: 78177-347-25

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1047755ethanol 75 % Topical SolutionPSN11
1047755ethanol 0.75 ML/ML Topical SolutionSCD11
1047755ethanol 75 % Topical SolutionSY11

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78177-347-222022-01-28C16284748780-1d6a99b39-7d11-a426-e053-dadaa90af4c2Hand Sanitizer
78177-347-232022-01-28C16284748780-1d6a99b39-7d11-a426-e053-dadaa90af4c2Hand Sanitizer
78177-347-242022-01-28C16284748780-1d6a99b39-7d11-a426-e053-dadaa90af4c2Hand Sanitizer
78177-347-252022-01-28C16284748780-1d6a99b39-7d11-a426-e053-dadaa90af4c2Hand Sanitizer
78177-347-262022-01-28C16284748780-1d6a99b39-7d11-a426-e053-dadaa90af4c2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78177-347-22Pure Army Hand Sanitizer500 mL in 1 BOTTLE, PLASTICLIQUID50011
78177-347-23Pure Army Hand Sanitizer4000 mL in 1 BOTTLE, PLASTICLIQUID400011
78177-347-24Pure Army Hand Sanitizer1000 mL in 1 BOTTLE, PLASTICLIQUID100011
78177-347-25Pure Army Hand Sanitizer20000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKLIQUID2000011
78177-347-26Pure Army Hand Sanitizer1000000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKLIQUID100000011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78177-347PURE ARMY HAND SANITIZER (ALCOHOL) LIQUID [PINTURAS Y RECUBRIMIENTOS RAVTECH, S.A. DE C.V.]11Legacy NDC, 5 package rows20201015_a657015f-b915-bd15-e053-2a95a90a142d.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
78177-34778177-347-22, 78177-347-23, 78177-347-24, 78177-347-25, 78177-347-26

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
b1aae01e-3db5-1d32-e053-2995a90a2b2da657015f-b915-bd15-e053-2a95a90a142d2020-10-14WarningsExact identifier
spl id: b1aae01e-3db5-1d32-e053-2995a90a2b2d
spl set id: a657015f-b915-bd15-e053-2a95a90a142d

Reported adverse events (FAERS/openFDA)#

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