FDA.reportPublic FDA data

PANROSA Instant Hand Sanitizer Clear

Manufacturer
PANROSA ENTERPRISES, INC.
Effective date
2021-10-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:44:21

Label at a glance#

ProductPANROSA Instant Hand Sanitizer Clear
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

hand sanitizer to help decrease bacteria on the skin. when water, soap & towel are not available. recommended for repeated use.

Dosage and administration

pump as need into your palms and thoroughly spread on both hands. rub into skin until dry.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • hand sanitizer to help decrease bacteria on the skin. when water, soap & towel are not available.
  • recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only.

Flammable. Keep away from fire or flame.

Do not apply around eyes.   

Do not use

OTC - DO NOT USE SECTION

in ears & mouth

When using this product.

OTC - WHEN USING SECTION

avoid contact with eyes. In case of contact flush eyes with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

redness or irritation develop and persist for more than 72 hours.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Children must be supervised in use of this product.

Directions

DOSAGE & ADMINISTRATION SECTION

  • pump as need into your palms and thoroughly spread on both hands.
  • rub into skin until dry.

Other information

SPL UNCLASSIFIED SECTION

  • store at 20°C (68°F to 77°F).
  • may discolor fabrics.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, carbomer, triethanolamine, glycerin, propylene glycol, fragrace, aloe barbadensis leaf juice, tocopheryl acetate

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling: 60ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

Package Labeling: 1L

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN3
581662ethanol 0.7 ML/ML Topical GelSCD3
581662ethanol 70 % Topical GelSY3
581662ethyl alcohol 70 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50302-003-002022-07-29C16284748780-1c7ccaba7-1c35-fd44-e053-dadaa90aa01bPANROSA Instant Hand Sanitizer Clear
50302-003-112022-07-29C16284748780-1c7ccaba7-1c35-fd44-e053-dadaa90aa01bPANROSA Instant Hand Sanitizer Clear
50302-003-602022-07-29C16284748780-1c7ccaba7-1c35-fd44-e053-dadaa90aa01bPANROSA Instant Hand Sanitizer Clear
50302-003-002021-10-20C16284748780-1c7ccaba7-1c35-fd44-e053-dadaa90aa01bPANROSA Instant Hand Sanitizer Clear
50302-003-112021-10-20C16284748780-1c7ccaba7-1c35-fd44-e053-dadaa90aa01bPANROSA Instant Hand Sanitizer Clear
50302-003-602021-10-20C16284748780-1c7ccaba7-1c35-fd44-e053-dadaa90aa01bPANROSA Instant Hand Sanitizer Clear
50302-003-002021-07-23C16284748780-1c7ccaba7-1c35-fd44-e053-dadaa90aa01bPANROSA Instant Hand Sanitizer Clear
50302-003-112021-07-23C16284748780-1c7ccaba7-1c35-fd44-e053-dadaa90aa01bPANROSA Instant Hand Sanitizer Clear
50302-003-602021-07-23C16284748780-1c7ccaba7-1c35-fd44-e053-dadaa90aa01bPANROSA Instant Hand Sanitizer Clear

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50302-003-00PANROSA Instant Hand Sanitizer Clear237 mL in 1 BOTTLEGEL2373
50302-003-11PANROSA Instant Hand Sanitizer Clear1000 mL in 1 BOTTLEGEL10003
50302-003-60PANROSA Instant Hand Sanitizer Clear60 mL in 1 BOTTLEGEL603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50302-003PANROSA INSTANT HAND SANITIZER CLEAR (ALCOHOL) GEL [PANROSA ENTERPRISES, INC.]3Legacy NDC, 3 package rows20211021_9e3a5926-2d8f-78ce-e053-2a95a90aae22.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
50302-00350302-003-00, 50302-003-60, 50302-003-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
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
ceceb090-9a8d-ba50-e053-2995a90a98fd9e3a5926-2d8f-78ce-e053-2a95a90aae222021-10-20WarningsExact identifier
spl id: ceceb090-9a8d-ba50-e053-2995a90a98fd
spl set id: 9e3a5926-2d8f-78ce-e053-2a95a90aae22

Reported adverse events (FAERS/openFDA)#

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