FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
First Step Safety Products Corporation | Zhejiang Enchant Cosmetic Co., Ltd.
Effective date
2020-07-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:20:03

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Wet hands with product and rub briskly until dry.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 68% v/v.

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Use for handwashing to decrease bacteria on the 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

OTC - WHEN USING SECTION

When using this product for external use on hands only. In case of contact with eyes, rinse with water.

OTC - STOP USE SECTION

Stop use and ask a doctor If irritation and redness develops or presists.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Wet hands with product and rub briskly until dry.

OTHER SAFETY INFORMATION

Do not store above 100F.
May discolor some fabrics.
Harmful to wood finishes and plastics.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Acrylates Copolymer, Aminomethyl propanol, Aloe Barbadensis Leaf Juice, Sodium Hyaluronate, Fragrance

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

236 mL in 1 BOTTLE NDC: 79195-001-01 236mL label236mL label 236mL label236mL label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79195-001-012022-01-28C16284748780-1d6a99b39-f78c-a426-e053-dadaa90af4c2First Step Safety Products Corporation 236mL Hand Sanitizer 79195-001-01

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79195-001-01Hand Sanitizer236 mL in 1 BOTTLEGEL2363

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79195-001HAND SANITIZER GEL [FIRST STEP SAFETY PRODUCTS CORPORATION]3Legacy NDC, 1 package rows20200704_a9320ab8-3ead-01ee-e053-2a95a90a260c.zip

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
79195-00179195-001-01

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
HYALURONATE SODIUMYSE9PPT4THIACT
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)JZ1374NL9EIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
ALOE VERA LEAFZY81Z83H0XIACT
LEMON24RS0A988OIACT

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
a998fa02-a24b-1a3c-e053-2a95a90a34dea9320ab8-3ead-01ee-e053-2a95a90a260c2020-07-04WarningsExact identifier
spl id: a998fa02-a24b-1a3c-e053-2a95a90a34de
spl set id: a9320ab8-3ead-01ee-e053-2a95a90a260c

Reported adverse events (FAERS/openFDA)#

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