FDA.reportPublic FDA data

Summer Breeze Hand Sanitizer

Manufacturer
Reaction Retail, LLC
Effective date
2020-08-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:24:35

Label at a glance#

ProductSummer Breeze Hand Sanitizer
Active ingredientALCOHOL
Label structure7 sections

Indications and uses

Hand sanitizer to help decrease bacteria on the skin.

Dosage and administration

Squirt as needed into your palms and thoroughly spread on both hands. Rub into skin until dry.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses:

INDICATIONS & USAGE SECTION

Hand sanitizer to help decrease bacteria on the skin.

Warnings:

WARNINGS SECTION

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

Stop use and ask doctor 

OTC - STOP USE SECTION

if irritation or rash appears and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a doctor right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Squirt as needed into your palms and thoroughly spread on both hands. Rub into skin until dry.

Other Information:

SPL UNCLASSIFIED SECTION

Store below 118°F.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Aqua (Water), Propylene Glycol, Glycerin, Aloe Barbadensis Leaf Juice Parfum (Fragrance) Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Citric Acid, Potassium Sorbate, Sodium Benzoate, Sucrose, Zea Mays (Corn) Starch, Hydroxypropyl Methylcellulose, Polyvinyl Alcohol, BHT, Benzyl Salicylate, Linalool, Limonene, CI 77267 (D&C Black No.3), CI 42090 (FD&C Blue No.1).

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN1
1305100ethanol 0.75 ML/ML Topical GelSCD1
1305100ethanol 75 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80026-001-352023-01-30C16284748780-1f386c64a-310e-0266-e053-dadaa90a7c1aSummer Breeze Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80026-001-35Summer Breeze Hand Sanitizer35 mL in 1 BOTTLEGEL351

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80026-001SUMMER BREEZE HAND SANITIZER (ALCOHOL) GEL [REACTION RETAIL, LLC]1Legacy NDC, 1 package rows20200813_acafb8d9-06af-ebd1-e053-2a95a90ad640.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80026-00180026-001-35

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
TROLAMINE9O3K93S3TKIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
SUCROSEC151H8M554IACT
CORN0N8672707OIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
BENZYL SALICYLATEWAO5MNK9TUIACT
LINALOOL, (+/-)-D81QY6I88EIACT
LIMONENE, (+)-GFD7C86Q1WIACT
D&C BLACK NO. 24XYU5U00C4IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
ALCOHOL3K9958V90MACTIB

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
acafb8d9-06b0-ebd1-e053-2a95a90ad640acafb8d9-06af-ebd1-e053-2a95a90ad6402020-08-12WarningsExact identifier
spl id: acafb8d9-06b0-ebd1-e053-2a95a90ad640
spl set id: acafb8d9-06af-ebd1-e053-2a95a90ad640

Reported adverse events (FAERS/openFDA)#

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