FDA.reportPublic FDA data

PAPA MADE

Manufacturer
BBIM INC
Effective date
2020-03-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:04:00

Label at a glance#

ProductPAPA MADE
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

Hand sanitizer to help reduce bacteria on the skin.

Dosage and administration

spray enough product on your palm to cover hands and rub hands together briskly until dry.  children under 6 years of age should be supervised when using Papa Made.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 80% v/v

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria on the skin.

Warnings

WARNINGS SECTION

Flammable, keep away from fire or flame

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not use in or near the eyes
  • in case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or rash appears and lasts

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help right away or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • spray enough product on your palm to cover hands and rub hands together briskly until dry. 
  • children under 6 years of age should be supervised when using Papa Made.

Other information

SPL UNCLASSIFIED SECTION

  • Store below 1100C (430F). 
  • May discolor certain fabrics or surfaces

Inactive ingredient

INACTIVE INGREDIENT SECTION

Water, Isopropyl Alcohol, Glycerol, Aloe vera, Peppermint oil, Tea tree oil

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN1
1039339ethanol 0.8 ML/ML Topical SolutionSCD1
1039339ethanol 80 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73709-001-012022-01-28C16284748780-1d6a99b39-d508-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73709-001-01PAPA MADE60 mL in 1 BOTTLE, SPRAYLIQUID601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73709-001PAPA MADE (ETHYL ALCOHOL 80%) LIQUID [BBIM INC]1Legacy NDC, 1 package rows20200318_8de94a9b-dac2-4150-88b4-5cea9f6595eb.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73709-00173709-001-01

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
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
PEPPERMINT OILAV092KU4JHIACT
TEA TREE OILVIF565UC2GIACT
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT

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
a93f0640-561b-441c-b147-6dce30e878138de94a9b-dac2-4150-88b4-5cea9f6595eb2020-03-17WarningsExact identifier
spl id: a93f0640-561b-441c-b147-6dce30e87813
spl set id: 8de94a9b-dac2-4150-88b4-5cea9f6595eb

Reported adverse events (FAERS/openFDA)#

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