PFA

Manufacturer
BLUE SEA AEROSOL & DAILY CARE CO., LTD
Effective date
2021-06-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:40:45

Label at a glance#

ProductPFA
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%(v/v)

Purpose

OTC - PURPOSE SECTION

Purpose: Antimicrobial

Use

INDICATIONS & USAGE SECTION

Hand sanitizing to help reduce bacteria on the skin.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from fire or flame

OTC - WHEN USING SECTION

When using this product avoid contact with the eyes. In case of contact, flush eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation and redness develops or persists.

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

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

  • Store below 110F (43C)
  • 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 - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72119-005-01PFA2 mL in 1 POUCHGEL21
72119-005-02PFA60 mL in 1 BOTTLE, PLASTICGEL601
72119-005-03PFA500 mL in 1 BOTTLE, PUMPGEL5001
72119-005-04PFA237 mL in 1 BOTTLE, PUMPGEL2371
72119-005-05PFA375 mL in 1 BOTTLE, PUMPGEL3751
72119-005-06PFA80 mL in 1 BOTTLE, PLASTICGEL801
72119-005-07PFA100 mL in 1 BOTTLE, PLASTICGEL1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72119-005PFA (ALCOHOL) GEL [BLUE SEA AEROSOL & DAILY CARE CO., LTD]1Legacy NDC, 7 package rows20210608_c3cda57f-c453-1dc1-e053-2995a90adfff.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72119-00572119-005-02, 72119-005-01, 72119-005-03, 72119-005-04, 72119-005-05, 72119-005-06, 72119-005-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
c3cd9f3c-a464-9a32-e053-2995a90a4f9dc3cda57f-c453-1dc1-e053-2995a90adfff2021-06-02WarningsExact identifier
spl id: c3cd9f3c-a464-9a32-e053-2995a90a4f9d
spl set id: c3cda57f-c453-1dc1-e053-2995a90adfff

Reported adverse events (FAERS/openFDA)#

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