FDA.reportPublic FDA data

PL-0591

Manufacturer
Broder Bros Co., | Prime Resources Corp | Yuyao Jessie Commodity Co., Ltd.
Effective date
2019-09-06
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-02 00:13:10

Label at a glance#

ProductPL-0591
Active ingredientALCOHOL
Label structure9 sections

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping For children under 6 use only under adult supervision. Not recommended for infants.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol (62%)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

for hand-washing to decrease bacteria on skin PL-4142 Back LabelPL-4142 Back Label

Warnings

WARNINGS SECTION

Flammable. Keep away from heat and flame.

Warnings

WARNINGS SECTION

For external use only.

Warnings

OTC - DO NOT USE SECTION

When using this product do not use in or near the eyes. In case of contact with eyes, flush thoroughly with water.

Warnings

OTC - STOP USE SECTION

Stop use & ask a doctor if skin irritation develops.

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet hands thoroughly with product and allow to dry without wiping
  • For children under 6 use only under adult supervision.
  • Not recommended for infants.

Other Information

OTHER SAFETY INFORMATION

  • Do not store above 105 F (40.55 C)
  • May discolor some fabrics
  • Harmful to wood finishes and plastics

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water.

Questions?

OTC - QUESTIONS SECTION

1-800-873-7746 M-F 8am-5pm EST

OTHER SAFETY INFORMATION

Lot no:

Use by:

Made in China

Distributed by: Prime Resource Corp Bridgeport, CT 06610

Hand Sanitizer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hand Sanitizer

Net wt. 0.66 FL OZ (19.52 mL) PL-4142 Front LabelPL-4142 Front Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71513-414-012022-11-28C16284748780-1c7ccaba7-128d-fd44-e053-dadaa90aa01b5668f6e3-233f-3f94-e054-00144ff8d46c
71513-414-012021-07-23C16284748780-1c7ccaba7-128d-fd44-e053-dadaa90aa01b5668f6e3-233f-3f94-e054-00144ff8d46c

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
71513-41471513-414-01

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
TROLAMINE9O3K93S3TKIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

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
ee8c2f2b-c5a4-7bbe-e053-2995a90a02dd5668f6e3-233f-3f94-e054-00144ff8d46c2022-11-28WarningsExact identifier
spl set id: 5668f6e3-233f-3f94-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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