FDA.reportPublic FDA data

Sani Spire Hand Sanitizer Gel

Manufacturer
Kira Labs Inc
Effective date
2021-07-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:40:59

Label at a glance#

ProductSani Spire Hand Sanitizer
Active ingredientALCOHOL
Label structure7 sections

Dosage and administration

• Put enough product in your palm to cover hands and rub hands together until dry. • Children under 6 years should be supervised when using this product.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use(s)

INDICATIONS & USAGE SECTION

• Hand Sanitizer to help decrease bacteria on skin.

Warnings

WARNINGS SECTION

Flammable. Keep away from fire or flame.

For external use only.

Do not use

OTC - DO NOT USE SECTION

• in children less than 2 months of age • on open skin wounds

When using this product

OTC - WHEN USING SECTION

Keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

• Put enough product in your palm to cover hands and rub hands together until dry.

• Children under 6 years should be supervised when using this product.

Other information

SPL UNCLASSIFIED SECTION

Do not store above 104°F / 40°C

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Fragrance, PEG-6, Glycerin, AMP-Acrylates/Vinyl Isodecanoate Crosspolymer, Propylene Glycol, Aloe Barbadensis Leaf Juice, Tocopherol

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

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
77816-51177816-511-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
TOCOPHEROLR0ZB2556P8IACT
ALCOHOL3K9958V90MACTIB
RAPIDGEL EZ133JH4A7R2KIACT

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
c6ef5838-a4fb-5c36-e053-2995a90a57ffb1b69a37-6cc8-fa8a-e053-2995a90a49f52021-07-12WarningsExact identifier
spl id: c6ef5838-a4fb-5c36-e053-2995a90a57ff
spl set id: b1b69a37-6cc8-fa8a-e053-2995a90a49f5

Reported adverse events (FAERS/openFDA)#

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