Hand Sanitizer

Manufacturer
Shantou Shengmei Biotechnology Co., Ltd.
Effective date
2020-04-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:06:48

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Alcohol 75% v/v. Purpose: Antiseptic

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria on the skin. Recommend for repeated use. For use when soap and water are not available.

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame. Do not use in children less than 2 months of age on open skin wounds.

OTC - WHEN USING SECTION

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children. If sallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product.

OTHER SAFETY INFORMATION

Store between 15-30C (59-86F). Avoid freezing and excessive heat above 40C (104F).

This product can effectively kill 99.99% Escherichia coli, Staphylococcus aureus, Candida albicans, Pseudomonas aeruginosa under experimental conditions. The results are for reference only.

INACTIVE INGREDIENT SECTION

Aqua, Hydrolyzed Jojoba Esters, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine ,Aloe Barbadensis Leaf Juice Powder, Citric Acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

55450-004-01 500mL

PDPPDP

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55450-004-012022-01-28C16284748780-1d6a99b39-89ed-a426-e053-dadaa90af4c2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55450-004-01Hand Sanitizer500 mL in 1 BOTTLEGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55450-004HAND SANITIZER GEL [SHANTOU SHENGMEI BIOTECHNOLOGY CO., LTD.]1Legacy NDC, 1 package rows20200418_a38264ba-2b94-4dcb-e053-2a95a90a7c26.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
55450-00455450-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML · Source PDF

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
a38264ba-2b93-4dcb-e053-2a95a90a7c26a38264ba-2b94-4dcb-e053-2a95a90a7c262020-04-17WarningsExact identifier
spl id: a38264ba-2b93-4dcb-e053-2a95a90a7c26
spl set id: a38264ba-2b94-4dcb-e053-2a95a90a7c26

Reported adverse events (FAERS/openFDA)#

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