Poly San Hand Sanitizer

Manufacturer
US Polychemical Holding Corporation
Effective date
2020-04-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:18:03

Label at a glance#

ProductPoly San Hand Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure11 sections

Label contents#

Full prescribing information#

Poly San Hand Sanitizer;  Purpose

OTC - PURPOSE SECTION

Purpose: Antimicrobial 

Poly San Hand Sanitizer; Active Ingredient Section

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Isopropyl Alcohol.....75%(v/v)

Poly San Hand Sanitizer; Indications & Usage Section

INDICATIONS & USAGE SECTION

Use: Hand sanitizer tTo help reduce the amount of bacteria on the skin.

Poly San Hand Sanitzer; Do Not Use Section

OTC - DO NOT USE SECTION

For external use only,do not use

• on children less than 2 months of age

• on an open skin wound

• in or near the eyes, ears or mouth

In case of contact, rinse eyes thoroughly with water

Poly San Hand Sanitzer; Warnings  Section

WARNINGS SECTION

Warnings: Flammable, keep away from fire or flame.

Poly San Hand Sanitizer Gel; Stop use and ask Doctor if section 

OTC - STOP USE SECTION

Stop use and ask Doctor if irritation appears and lasts

Poly San Hand Sanitizer; Keep out of reach of children section

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. 

Poly San Hand Sanitizer; Dosage & Administration Section

DOSAGE & ADMINISTRATION SECTION

Directions: Put enough of the product in your palm to cover hands and rub hands together briskly until dry.

Children under the age of 6 should be supervised when using this product

Poly San Hand Sanitizer; Inactive Ingredient Section

INACTIVE INGREDIENT SECTION

Inactive ingredients: Water(Aqua), glycerol, Fragrance (Parfum)

Poly San Hand Sanitizer Gel; Other Safety Information 

OTHER SAFETY INFORMATION

Other information: At or below 110°F (43°C) may discolor certain fabrics or surfaces.

Avoid freezing and excessive heat.

Store between 59-86°F (15-30°C).

Poly San Hand Sanitzer Drug Facts Label  The following Hand sanitizer is manufactured according to the 1994 TFM for OTC antiseptic drug products that published in the Federal Register of June 17, 1994 (59 FR 31402).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts

Active Ingredient: Isopropanol 75% (v/v)  Purpose: Antimicrobial

Use: Hand sanitizer to help reduce bacteria on skin

Warnings: Flammable, keep away from fire or flame.

For external use only, do not use

• on children less than 2 months of age

• on an open skin wound

• in or near the eyes, ears or mouth

In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if irritation or rash appears and lasts

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions: Put enough of the product in your palm to cover hands and rub hands together briskly until dry

Children under the age of 6 should be supervised when using this product

Other information: At or below 110°F (43°C) may discolor certain fabrics or surfaces.

Avoid freezing and excessive heat.

Store between 59-86°F (15-30°C).

Inactive ingredients: Water(Aqua),glycerol, fragrance (Parfum)

Poly San Hand Sanitizer Gallon Size 1.jpg

Poly San Hand Sanitizer Gallon Size 1.jpgPoly San Hand Sanitizer Gallon Size 1.jpg

Poly San Hand Sanitizer Qt size 1.jpg

Poly San Hand Sanitizer Qt size 1.jpgPoly San Hand Sanitizer Qt size 1.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039900isopropyl alcohol 75 % Topical SolutionPSN1
1039900isopropyl alcohol 0.75 ML/ML Topical SolutionSCD1
1039900isopropyl alcohol 75 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76644-0001-1Poly San Hand Sanitizer3.785 L in 1 BOTTLELIQUID3.7851
76644-0001-2Poly San Hand Sanitizer0.946 L in 1 BOTTLE, SPRAYLIQUID0.9461

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76644-0001POLY SAN HAND SANITIZER (ISOPROPYL ALCOHOL) LIQUID [US POLYCHEMICAL HOLDING CORPORATION]1Legacy NDC, 2 package rows20200618_6b2f07f0-3b56-451b-bd21-0c0e784e713b.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76644-000176644-0001-1, 76644-0001-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

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
d976b100-f43c-4efa-8011-9040721eae236b2f07f0-3b56-451b-bd21-0c0e784e713b2020-04-30WarningsExact identifier
spl id: d976b100-f43c-4efa-8011-9040721eae23
spl set id: 6b2f07f0-3b56-451b-bd21-0c0e784e713b

Reported adverse events (FAERS/openFDA)#

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