FDA.reportPublic FDA data

HAND SANITIZER

Manufacturer
SCENT THEORY PRODUCTS LLC
Effective date
2022-01-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:16:20

Label at a glance#

ProductHAND SANITIZER
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

FOR HANDWASHING TO DECREASE BACTERIA ON THE SKIN

Dosage and administration

WET HANDS THOROUGHLY WITH PRODUCT AND ALLOW TO DRY WITHOUT WIPING. FOR CHILDREN UNDER 6, USE ONLY UNDER ADULT SUPERVISION. NOT RECOMMENDED FOR INFANTS.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

ETHYL ALCOHOL 70% V/V

PURPOSE

OTC - PURPOSE SECTION

ANTISEPTIC

USES

INDICATIONS & USAGE SECTION

FOR HANDWASHING TO DECREASE BACTERIA ON THE SKIN

WARNINGS

WARNINGS SECTION

For external use only: hands

Flammable. Keep away from fire or flame.

When using this product

  • Keep out of eyes. In case of contact with eyes flush thoroughly with water.
  • Avoid contact with broken skin.
  • Do not inhale or ingest.

Stop use and ask a doctor if

  • irritation and redness develop
  • condition persists for more than 72 hours

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.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • WET HANDS THOROUGHLY WITH PRODUCT AND ALLOW TO DRY WITHOUT WIPING.
  • FOR CHILDREN UNDER 6, USE ONLY UNDER ADULT SUPERVISION.
  • NOT RECOMMENDED FOR INFANTS.

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • DO NOT STORE ABOVE 105 DEGREES F
  • MAY DISCOLOR SOME FABRICS
  • HARMFUL TO WOOD FINISHES AND PLASTICS

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

CHERRY BLOSSOM: Water (Aqua), PEG-40 Hydrogenated Castor Oil, Fragrance (Parfum), Carbofner, Aminomethyl Propanol, Aloe Barbadensis Extract, Butylene Glycol, 1,2-Hexanediol, Caprylhydroxamic Acid, Citric Acid, Disodium EDTA, Tocopheryl Acetate, Red 33, Yellow 5

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL (front)_Mia and Tess_30mL01b LBL (front)_Mia and Tess_30mL

01b LBL (back)_Mia and Tess_30mL01b LBL (back)_Mia and Tess_30mL

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76891-13176891-131-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
WATER059QF0KO0RIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ALCOHOL3K9958V90MACTIB
EDETATE DISODIUM7FLD91C86KIACT
ALOE VERA LEAFZY81Z83H0XIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C YELLOW NO. 5I753WB2F1MIACT

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
d5b808bc-ba3e-4047-e053-2a95a90a89a2c72d9e20-24f5-c6aa-e053-2995a90a31842022-01-16WarningsExact identifier
spl id: d5b808bc-ba3e-4047-e053-2a95a90a89a2
spl set id: c72d9e20-24f5-c6aa-e053-2995a90a3184

Reported adverse events (FAERS/openFDA)#

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