FDA.reportPublic FDA data

Puresan

Manufacturer
Inopak, Ltd
Effective date
2020-02-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:41:50

Label at a glance#

ProductPuresan Ocean Breeze
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

To decrease bacteria on the skin that potentially can cause disease. Recommended for repeated use

Dosage and administration

Apply sufficient amount of product to your palm to cover both hands. Rub until dry.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Keep away from 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 right away. Children should be supervised by an adult when using this product.

Uses

INDICATIONS & USAGE SECTION

To decrease bacteria on the skin that potentially can cause disease. Recommended for repeated use

Warnings

WARNINGS SECTION

Flammable, keep away from heat or flame. For external use only. Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water. Stop use and ask a doctor if irritation and redness develop or if condition persists for more than 72 hours. Keep out of reach of children. If swallowed. Get medical help or contact a Poison Control Center right away. Children should be supervised by an adult when using this product.

other information

OTHER SAFETY INFORMATION

May discolor certain fabrics and surfaces.

Stop use

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation and redness develop or if condition persists for more than 72 hours.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply sufficient amount of product to your palm to cover both hands. Rub until dry.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C 10/30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, FD&C Blue 1, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, PEG/PPG-18/18 Dimethicone, Triethanolamine, Vitamin E, Water

Puresan Ocean Breeze front label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

 puresan

 Cleaning innovations

Kills 99.9%                           Ocean Breeze Scented

 of germs                             Hand

                                                Sanitizer

√ Ultimate protection

√ Ultra moisturizing

√ Leaves hands feeling ultra soft

Net. Wt. 18 fl. Oz.

Front labelFront label

puresan ocean breeze back label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

                                                                                                        AVRO-307DF Rev. 1.1

Drug Facts

Active Ingredient                             Purpose

Ethyl Alcohol 70% v/v …………….. Antiseptic

Uses: To decrease bacteria on the skin that potentially can cause disease. Recommended for repeated use

Warnings: Flammable, keep away from heat or flame. For external use only. Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water. Stop use and ask a doctor if irritation and redness develop or if condition persists for more than 72 hours. Keep out of reach of children. If swallowed. Get medical help or contact a Poison Control Center right away. Children should be supervised by an adult when using this product.

Directions: Apply sufficient amount of product to your palm to cover both hands. Rub until dry.

Other Information: May discolor certain fabrics and surfaces.

Inactive Ingredients:

Acrylates/C 10/30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, FD&C Blue 1, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, PEG/PPG-18/18 Dimethicone, Triethanolamine, Vitamin E, Water

                                                                                                                NOT TESTED ON ANIMALS

Got a question?

1-855-500-8080                                 puresan                                               Puresan USA

 puresanusa.com                             cleaning innovations                       Sparta, NJ 07871

Back labelBack label

Case label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

puresan                                                               puresanusa.com

cleaning innovations                                       (855) 500-8080

ITEM # 307

PURESAN Instant Hand Sanitizer Gel

18oz pump bottles OB case of 16 bottles                                                               BAR CODE

QTY 16                                                                                                                                  37654 23425

Bottles

AVRO-307-CS     Rev: 1.0

Case labelCase label

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58575-14158575-141-01, 58575-141-02

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
ALCOHOL3K9958V90MACTIB
PERFLUOROALKYLETHYL ACRYLATES (C6-C14)TKA54G588XIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
ISOPROPYL ALCOHOLND2M416302IACT
PEG/PPG-18/18 DIMETHICONE9H0AO7T794IACT
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

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
d0245586-6b1f-5356-e053-2995a90a7ed9217b7678-16ba-4979-833c-e0386e25b5982021-11-06WarningsExact identifier
spl set id: 217b7678-16ba-4979-833c-e0386e25b598

Reported adverse events (FAERS/openFDA)#

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