FDA.reportPublic FDA data

9054 Hand Sanitizer

Manufacturer
LMZ (Jiangsu) Industrial Co.,Ltd
Effective date
2021-01-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:57:34

Label at a glance#

Product9054 Hand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

For Hand Sanitizing

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping. For children under 6 age use only under adult supervision. Not recommended for infants.

Storage and handling

Do not store above 105°F. May discolor some fabrics.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

For Hand Sanitizing

Warnings

WARNINGS SECTION

For external use only-hands.
Flammable. Keep away from heat and flame.

Do not use

OTC - DO NOT USE SECTION

Do not inhale or ingest.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if skin irritation develops.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or call 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 age use only under adult supervision.
Not recommended for infants.

Other Information

STORAGE AND HANDLING SECTION

Do not store above 105°F.
May discolor some fabrics.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Propylene Glycol, Carbomer, Glycerol, Triethanolamine, Fragrance, Tocopheryl acetate

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

57816-008-01 30ml GEL

57816-008-01 30ml GEL57816-008-01 30ml GEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57816-008-012022-12-20C16284748780-1e4f33bdf-a2bb-d8a0-e053-dadaa90a6e4e57816-008 9054 Hand Sanitizer
57816-008-012022-07-29C16284748780-1e4f33bdf-a2bb-d8a0-e053-dadaa90a6e4e57816-008 9054 Hand Sanitizer

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
57816-00857816-008-01

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
ALCOHOL3K9958V90MACTIB
FRAGRANCE FRESH CITRUS FLORAL ORC1501495OU4GI2R2WBIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
f04eaf2f-4d6b-d285-e053-2a95a90a2ab8b86ecd00-c4f8-4085-e053-2a95a90afd142022-12-20WarningsExact identifier
spl set id: b86ecd00-c4f8-4085-e053-2a95a90afd14

Reported adverse events (FAERS/openFDA)#

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