FDA.reportPublic FDA data

PFA FOR HAND SANITIZER

Manufacturer
STRONGHOLD TRADING LLC | S-ONE PHARMACEUTICAL INC
Effective date
2021-12-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:24:49

Label at a glance#

ProductPFA FOR HAND SANITIZER
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

Put enough product in the palm to cover hands & rub together briskly the liquid is dry Children under 6 should be supervised when using Sanitizers.

Storage and handling

Store below 110°F (43°C) May discolor certain fabrics or surfaces.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

DOSAGE & ADMINISTRATION SECTION

Hand sanitizing to help reduce bacteria on the skin.

Warnings

WARNINGS SECTION

For external use only.

Flammable. Keep away from fire or flame.

When using this product

OTC - WHEN USING SECTION

avoid contact with the eyes.

In case of contact, flush eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation and redness develops and persists.

Keep out of reach of children.

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 immediately.

Directions

INDICATIONS & USAGE SECTION

  • Put enough product in the palm to cover hands & rub together briskly the liquid is dry
  • Children under 6 should be supervised when using Sanitizers.

Other information

STORAGE AND HANDLING SECTION

  • Store below 110°F (43°C)
  • May discolor certain fabrics or surfaces.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer, Glycerin, Grapefruit seed extract, Mentha Oil, Propylene glycol, Purified water, Sophora extract, Triethanolamine

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

80969-040-0380969-040-03

80969-040-0480969-040-04

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80969-040-032023-03-26C16284748780-1f386c64a-2c3d-0266-e053-dadaa90a7c1a80969-040 PFA FOR HAND SANITIZER
80969-040-042023-03-26C16284748780-1f386c64a-2c3d-0266-e053-dadaa90a7c1a80969-040 PFA FOR HAND SANITIZER
80969-040-032023-01-30C16284748780-1f386c64a-2c3d-0266-e053-dadaa90a7c1a80969-040 PFA FOR HAND SANITIZER
80969-040-042023-01-30C16284748780-1f386c64a-2c3d-0266-e053-dadaa90a7c1a80969-040 PFA FOR HAND SANITIZER

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80969-04080969-040-03, 80969-040-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
MORUS ALBA BARK7O71A48NDPIACT
CITRUS PARADISI SEED12F08874Y7IACT

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
0d64bcbe-af9c-2662-e063-6294a90ac149d11cac12-91cc-459e-e053-2995a90a7d962023-12-26WarningsExact identifier
spl set id: d11cac12-91cc-459e-e053-2995a90a7d96

Reported adverse events (FAERS/openFDA)#

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