FDA.reportPublic FDA data

piperwaiHandSanitizerminty

Manufacturer
Piperwai, LLC | Cospro Development Corp
Effective date
2021-03-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:39:20

Label at a glance#

ProductpiperwaiHandSanitizerminty
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Pump onto dry hands as needed coating evenly. Allow to dry without wiping Supervise children under 6 years old Not recommended for infants.

Storage and handling

Do not store above 105F

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

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

The hand rub 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) (62%, in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol.
  3. Sterile distilled water or boiled cold water.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 62%. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Rub

Use

INDICATIONS & USAGE SECTION

Reduces the amount of bacteria on hands. Recommended for repeated use.

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

aviod contact with eyes.
In case of contact, flush thoroughly with water.

OTC - WHEN USING SECTION

When using this product aviod contact with eyes. In case of contact, flush thoroughly with water.
Stop use and ask a doctor if irritation occurs.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs.

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

Pump onto dry hands as needed coating evenly.
Allow to dry without wiping
Supervise children under 6 years old
Not recommended for infants.

Other information

STORAGE AND HANDLING SECTION

Do not store above 105F

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Aloe Barbadensis Leaf Juice, Carbomer, Rosmarinus Officinalis (Rosemary) Leaf Oil, Mentha Piperita (Peppermint) Oil, Aminomethyl Propanol

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81741-111-012022-07-29C16284748780-1e4f33bdf-a3a9-d8a0-e053-dadaa90a6e4e03f4f5c7-e118-4a17-9473-22b4f68d8f42

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81741-111-01piperwaiHandSanitizerminty50 mL in 1 BOTTLESOLUTION501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81741-111PIPERWAIHANDSANITIZERMINTY (ALCOHOL) SOLUTION [PIPERWAI, LLC]1Legacy NDC, 1 package rows20210401_03f4f5c7-e118-4a17-9473-22b4f68d8f42.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81741-11181741-111-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
ROSEMARYIJ67X351P9IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
PEPPERMINT OILAV092KU4JHIACT
GLYCERINPDC6A3C0OXIACT
ALOEV5VD430YW9IACT
WATER059QF0KO0RIACT

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
2ab9b68e-9000-46d0-903f-3e8e61e3234403f4f5c7-e118-4a17-9473-22b4f68d8f422021-03-31WarningsExact identifier
spl id: 2ab9b68e-9000-46d0-903f-3e8e61e32344
spl set id: 03f4f5c7-e118-4a17-9473-22b4f68d8f42

Reported adverse events (FAERS/openFDA)#

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